ASQ St. Louis Job Posting

Director Management Engineering - HCA North Texas

2008-12-03T15:10:00.001-06:00

HCA, the nation's largest for-profit healthcare provider, has an immediate opening for a Director of Management Engineering in the North Texas Division. Based in Dallas, this Division consists of nine hospitals and associated ASCs and Imaging centers. As a member of the Division's Senior Management Team, the Director identifies process and productivity improvement opportunities and works with Division, hospital senior executive teams, and department managers to achieve improved results. The Director also participates on company-wide improvement initiatives. Minimum requirements include a B.S. in Industrial Engineering and at least seven years of management engineering leadership responsibility, preferably in a multi-hospital system.

If interested and meet the minimum qualifications, please submit resume and salary history to Roger.Hendry@HCAHealthcare.com.

Quality Systems Analyst - Maverick Technologies

2008-10-31T13:46:00.001-06:00

The Quality Systems Analyst will be responsible for the following:

Reporting to the Director of Quality on Customer Service and Quality Program areas assigned.
Maintains the Quality Program and leads change management activities when improvements are identified and implemented in the Quality Program.
Prepares program guidelines, status reports and presentations for executive staff.
Performs audits of project team compliance to the Quality Program.
Provide administrative support as assigned by the Director of Quality.
Design and Implement Customer Feedback measurement systems, maintain and analyze data and prepare reports.
Develop training material, prepare lesson plans, and conduct Quality Program training.
Maintain the corporate database of personnel resumes and skills attributes.
Assist Director of Quality with helping MAVERICK Project Managers earn their PMP Certification and tracking progress.
Assist Director of Quality in tracking/maintaining Professional Engineer licensure data and professional development.
Assist Director of Quality with other Quality related initiatives as necessary.
Desire and ability to earn PMI PMP certification within one year.

Required Skills:

Education/experience requirements: Bachelors degree from an accredited educational institution authorized to grant degrees with at least 24 semester hours in any combination of the following fields: marketing, accounting, contracts, industrial management, quantitative methods, or organization and management.
Three (3) years of experience in a process improvement role with primary focus on project execution and customer service in a business to business environment.
Experience with administration of corporate Quality Programs.
Experience with certification processes such as ISO beneficial, but not required.
Experience/Training in structured quality methodologies such as Six Sigma or TQM strongly preferred.
Prior management or supervisory experience is preferred.
Experience working in a project or professional services delivery environment strongly preferred.
Must also possess working knowledge of MS Office Word, Excel, Access and be able to use online tools to support obtaining and analyzing metrics.
Strong oral, written and presentation skills including ability to interact with clients and MAVERICK teams in person and via phone.
Demonstrated process/quality improvement leadership.
Strong Analytical skills to review company wide performance data from customer feedback and prepare summary information for review by management and other employee stakeholders.
Ability to work with Regional operations to maintain compliance to the MAVERICK Quality Program. Ability to objectively perform audits of projects and identify areas to improve and best practices to incorporate into our processes.
Ability to manage and communicate both vertically within the Quality team and in a matrix project management environment.
Ability to adhere to and champion the MAVERICK Quality Program.
Office Work Environment with ability to work remotely as needed.
Independent as well as team work.

We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

Please visit our website at http://www.mavtechglobal.com/

If interested in the Quality Systems Analyst position, please contact Melissa Scott, Talent Acquisition Associate – MAVERICK Technologies, at Melissa.Scott@mavtechglobal.com.

Positions at Peninsula Regional Medical Center

2008-10-30T14:34:00.000-06:00

The nationally recognized Peninsula Regional Medical Center invites you to discover how "Our Experience Makes Your Experience Better."

In the field of medicine on the Delmarva Peninsula, it has always been essential to successful outcomes and partnerships that have grown strong and continue to shape the future of health care in the region where our 3,300 physicians, nurses, health care professionals and volunteers live and raise their families.

Since 1897, the 362 bed Peninsula Regional Medical Center team has been focused on providing our region with compassionate care and successful outcomes, dedicated to the complete satisfaction and safety of our patients and devoted to ensuring that everyone has access to cost-effective, high-quality care.

Medical Center leaders have spent nearly $150 million dollars in just the past decade on state-of-the-art clinical, surgical, medication dispensing, pharmaceutical, diagnostic imaging and information technologies. Most recently, we added the Peninisula's first daVinci Surgical System for prostate and cardiac surgery.

We were among the first 5% of all United States hospitals to pioneer bedside medication scanning for patient safety, installed one of the nation's first automated drug dispensing robots and electronic physician order entry to close the loop on medication and patient safety.

The region's most experienced health care team also delivers over 2,200 babies, treats over 75,000 patients in the Emergency/Trauma Center, performs more than 500 joint replacements and touches the lives of nearly 500,000 of our friends and neighbors each year through inpatient and outpatient services.

PRMC currently has two opportunities in the department of Operational Performance Improvement:

Improvement Consultant

While under direction of the Manager of Operational Performance Improvement, this position will be responsible for leading Performance Improvement teams using tools from Six Sigma, Lean, and other contemporary performance improvement methodologies, performing systems design and reengineering, leverage benchmarking and best practices to improve labor, supply and space utilization, as well as provide educational support to PI based content.

At least five years of experience with Bachelors degree in Industrial Engineering or Business Administration with concentration in Finance, Management, or Operations, or two years with Master's degree performing cost reduction/process improvement/systems engineering activities.

To apply please click here.

Analyst - Operational Performance Improvement

While under direction of the Manager of Operational Performance Improvement this position will be responsible for providing analytical support in the Operational Performance Improvement department. The focus of this work will be in both clinical and operational areas of resource management and performance improvement. This position will utilize various internal and external hospital systems to assist in the assessment of personnel productivity, supply utilization, and space utilization.

To apply please click here.

Principal Engineer, Quality (08006074) - Cardinal Health

2008-10-20T14:05:00.002-06:00

At Cardinal Health, we're developing the innovative products and services that make healthcare safer and more productive. Join a growing, global company genuinely committed to making a difference for our customers and communities.

What is expected of you and others at this level in Quality & Regulatory Affairs for functional success

Works to understand complex functional situations by paying attention to the details of the tasks at hand and by breaking them down into smaller pieces
Proactively develops and maintains broad knowledge of the technical disciplines in own functional area(s); applies broad knowledge of trends and suggests process improvements based on observations.
Uses deep subject matter/functional expertise, influence and process skills to help internal/external customers and stakeholders identify and meet their high priority needs while considering cultural and diversity implications.
Encourages informed Risk-taking and acts as a catalyst for innovation at Cardinal Health; generates practical, sustainable and creative options to solve problems and create business opportunities, while maximizing existing resources.
Champions and leads change initiatives; identifies the best approach for implementing strategic processes in light of cultural and diversity implications to help guide team(s) through change.

Accountabilities in this role

Maintains and assures compliance with appropriate regulations/standards relative to medical device design, engineering, manufacturing and distribution.
Establishes and/or improves product/process quality individually and through Focused Factory Team base problem solving efforts using Respiratory Care Total Quality tools.
Participates in the Material Review Board activities during process development of product and productions. Evaluates nonconformance reports as required; coordinate corrective action activities and complete follow-up evaluations to determine completion and effectiveness of corrective actions.
Coordinates supplier corrective action activities with purchasing and other departments as necessary for supplier quality issues.
Ensures proper validation of installation quality, operation quality and performance quality of equipment, documentation, processes through review of validation plans and subsequent audit(s) of those activities at the supplier’s location.
Provides technical guidance for supplier improvement activities
Reviews and evaluates Engineering Change Request/ Engineering Change Order for accuracy, effectiveness and compliance and provide support to the component change control board process.
Performs audits on supplier manufacturing processes to assure compliance at subassembly and system levels.
Provides design input(s) related to the quality during the design and development phase. Performs appropriate analyses and evaluations, as needed, to make recommended changes.

Qualifications

BA/BS degree in Mechanical Engineering and 3 years of industry experience as a Quality Engineer. Or A.S Degree in Mechanical Engineering and 7 years of industry experience as a Quality Engineer. Or 10 Years of medical device industry experience as a Quality Engineer.
Advanced degree preferred
4 -6 years applied experience
Knowledge of FDA regulations, Quality Control and Documentation
Proficient with MS Word, Excel and Access.

Please visit our job board at www.cardinalhealth.com/careers enter 08006074 in the "Keyword/Job Number" field

Process Improvement Engineer (Business Operations Consultant III)

2008-10-20T14:02:00.001-06:00

Position Summary:

Become part of one of the largest and most prestigious medical centers in the nation, Montefiore Medical Center. Take advantage of the opportunity to utilize the skills and talents you currently posses while developing additional ones that will support your career development in an institution that has been successful for over one hundred years. Establish yourself in this vast medical science complex and academic medical center that has been internationally recognized as a leader at the forefront of healthcare research, education, and social commitment.

Montefiore Medical Center is recruiting for a Process Improvement Engineer, to assist with workflow efficiencies, patient throughput assessments, internal process consultations, and implementation of value-added processes. As a member of the Business Information Systems and Management team, this position employs critical skill sets to address strategic leadership and planning and change management throughout the Medical Center. As a Level III Consultant, this engineer will utilize their expertise in the areas of work on process analysis, time and cost studies, facility design, process simulation, process and quality improvement, financial and organizational planning and information system design.

Minimum Qualifications:

Bachelor or Graduate Degree in Industrial or Systems Engineering with a focus on Management Engineering in Operations Research or Information Technology Minimum of three to five years of experience as a management engineer in health care settings (preferable in acute care).

Frequent Contacts:

Demonstrated professionalism in the ability to communicate with and present to senior management, medical staff, administrative staff and all members of the management team.

Special Skills Required:

Demonstrated knowledge of computer applications and database management, simulation modeling, process improvement skills, project management systems. Ability to handle multiple projects simultaneously.

Reports directly to the Director - Health Systems Engineering

We offer a competitive benefits package. Qualified candidates can email their resumes to: Yvette Sylvester E-mail: ysylvest@montefiore.org We are an equal opportunity employer.

Process/Quality Engineer - Chicago Area

2008-09-26T15:58:00.002-06:00

Job Order: DM0620-001-1311

Title: Process/Quality Engineer

Location: Chicago area

Summary:
Will lead the site quality team and also work closely with site safety and
productivity teams to continually improve on-site quality and safety
performance.

Responsibilities:
Will play a key technical role in plant operations through involvement in plant productivity improvements/supporting plant technical operations/ongoing manufacturing support/plant process improvement/capital project management/maintenance engineering/technology transfer/new product scale up and operator training and supervision.

This individual will help develop and update operating procedures, and work with the various department personnel to coordinate and ensure timely customer shipment and quality. He/she will also play a role in Six Sigma projects to improve product quality, productivity, customer service and costs.

Experience:

BS Degree in Chemical Engineering, Mechanical Engineering or equivalent
Minimum of 5-7 years in manufacturing/operational experience at a production facility. Prior experience in ISO management systems, OSHA, Six Sigma, and supervisory experience preferred.
Result oriented, excellent organizational skills, great communicator, and good inter-personal skills, demonstrates a sense of urgency and can affect change.
Able to act decisively, fact-based approach in problem solving, able to bring concepts to implementation, and excellent production mentality. Working knowledge of SPC, OSHA, ISO, and Six Sigma (preferred).

Compensation: Commensurate with experience

If you are interested in this opening, please email a copy of your resume
as an MS Word attachment to:

Brandon Trujillo
BCI Recruiting
(312) 460-8222 x112
brandon@bcius.com
www.bcius.com

Manager, Process Improvement and System Redesign - Chicago

2008-09-25T16:09:00.000-06:00

ACCESS Community Health Network in Chicago, IL is seeking a Manager of Process improvement and Systems Redesign. Access Community Health Network is the nation’s largest network of community health centers. The mission of Access Community Health Network is to provide high quality, community-based health care to all who need it, regardless of ability to pay. This mission is carried out daily through caring services, committed staff and strong connections to the communities served. With 50 health centers in the Chicagoland area, ACCESS serves over 200,000 low-income, medically underserved individuals annually, bringing them comprehensive health services at an affordable cost.

The Manager position will report to the Director of Process Improvement and Systems Redesign. This position is responsible for leading and implementing process improvement projects throughout the organization and drive results-oriented improvement using Lean Six Sigma and other process improvement tools.

Core Responsibilities Include:

Identify process improvement and systems redesign opportunities through the review and analys is of data, existing processes and practices.
Lead Lean Six Sigma project initiatives throughout the organization.
Assist project team with process flows for the implementation of the outpatient Practice Management and Electronic Health Record System.
Guide and direct business unit leaders in the development and implementation of process improvement and redesign initiatives
Leads multi-disciplinary process improvement efforts, collaboratively partners with department leaders to evaluate current levels of operational efficiency. Participates in the development of process improvement strategy and project plans.
Support the organization’s ongoing efforts to prepare for the Illinois Lincoln Award for Excellence and Baldrige National Quality Award, as well as remain Joint Commission accredited.

Qualifications:

Bachelor’s degree required. Masters degree preferred.
Previous health care experience required.
Black Belt training preferred.
Minimum of five years business process consulting or process improvement experience including implementation of LEAN, Six Sigma or other process improvement methodologies and tools. Proficient with PC applications, including Microsoft Office, Visio and Project.
Demonstrated experience in leading multi-disciplinary teams centered on quality, process and productivity improvement.
Excellent communication and presentation skills; project management skills and training; facilitation skills; self motivated, able to function independently in an environment of limited or remote supervision; Comfortable in a demanding and rapidly changing environment.
Ability to be assertive yet sensitive to business and organizational issues; Ability to collect, analyze and interpret both qualitative and quantitative data to draw appropriate conclusions; Ability to motivate others and overcome resistance; Ability to interact with all levels of management, including strong execut ive level communication s.

For additional information or to apply for this position please contact Jennifer Snow at snoje@accesscommunityhealth.net or Bessie Harris, Director of Process Improvement & Systems Redesign at harbess@accesscommunityhealth.net.

Calibration Technician - Quality Testing

2008-09-16T15:01:00.001-06:00

Quality Testing is a full service calibration lab looking for technicians with one year or more experience with calibrating calipers, height gauges, surface plates, gauge blocks, pressure gauges hardness testers, and ovens.

They will train as needed in the electronics calibration, such as ampmeters etc. Interested parties please E-mail: qa@qualitytesting.net for more information.

Website: www.qualitytesting.net
Phone # 314 770 0607
Fax 314 770 0103
E-mail: qa@qualitytesting.net

Management Engineer - HCA West Florida Division

2008-09-16T14:06:00.000-06:00

The West Florida Division of HCA is seeking a management engineer to push the process improvement initiative. This is a 16 hospital system in Tampa, FL that is part of the 170+ hospital company HCA.

Position Overview

Facilitates improvements in operating performance through fundamental rethinking and redesign of core processes.
Serves as primary link to the process improvement teams and natural working groups and implementation teams.
Enables key stakeholders' participation and acceptance of change efforts.
Directs a variety of management engineering projects and programs to provide management with statistical data in areas including information flow, cost containment, work standards, staffing levels, and productivity.
Develops and initiates a plan to educate departments on various topics related to productivity management and improvement strategies.
Works directly with staff, directors, and executive leaders to implement and maintain process improvement
Plans, coordinates and conducts studies to produce operational best-demonstrated practices; analyzes and evaluates departmental organization, processes, methods, and equipment
Recommends changes or improvements based on study results.
Develops methods for measuring outcomes against standards; assists in the identification of criteria and effective qualitative/quantitative measurement tools.
Makes presentations to a wide audience at the hospital and division levels. Must have extensive PC skills including spreadsheets, databases, Word Processing and presentation applications.
Must have strong written and presentation skills, as well as experience in process re-engineering and the application of quantitative analysis techniques as applied in a healthcare setting.

Contact Information
Please contact Adam Rudd if you are interested in the position.
Phone: 727-793-6011
Email: Adam.rudd@hcahealthcare.com

Division Director, Management Engineering

2008-08-05T23:36:00.002-06:00

The Director of Management Engineering develops and implements the strategic planning for staffing the Division, sets specific productivity goals to be accomplished, and directs the activities of the Division aimed toward meeting those strategic goals. The position is also responsible for complying with corporate policy and procedures, managing resources, promoting teamwork and maximizing internal and external customer satisfaction.

The position requires in-depth familiarity with hospital operations and health care industry practices and trends.
Consult with hospital and division leadership to develop and implement standard productivity models, under the guidance of the Group VP, Management Engineering.
Identify productivity problems and issues and communicate them to the appropriate facility and Division individual(s) and recommend solutions.
Coordinate program implementation with facility Human Resources departments.
Develop, oversee, and improve daily operations, policies, systems and procedures necessary to support cost reduction and system utilization goals.
Coordinate fiscal and operational measures and processes.
Establish and monitor appropriate indicators for maximum productivity, efficiency, and resource utilization.
Develop methods to collect and analyze data on effectiveness of programs.
Make presentations to a wide audience at the hospital and division levels.
Must have extensive PC skills including spreadsheets (Lotus & Excel), Word Processing and presentation applications (PowerPoint & Harvard Graphics).
Evaluate vendor proposals and implement as necessary to meet strategic goals.
Must have experience and knowledge of re-engineering and redesign as well as CQI and TQM methodologies as applied in a healthcare setting.
Must demonstrate ability to move beyond labor and productivity management by providing input toward areas such as resource consumption, supply management, business consolidations, and information systems utilization.
Perform additional duties as assigned.
Practice and adhere to the Code of Conduct and Mission, and values statement.

Requirements

Degree in related discipline (i.e. Industrial Engineering), with a business emphasis preferred.
Command of relevant CQI. Supply and labor management concepts, productivity experience in a healthcare environment required.
Communication – communicates clearly and concisely, verbally and in writing.
Advanced PC skills – demonstrates knowledge and or proficiency in financial reporting systems specifically Clear Access, FIS, Vista, etc.
Policies and Procedures – demonstrates knowledge and understanding of organizational policies, procedures and systems.
Performs detailed work, which requires a high level of concentration and excellent judgment making skills, even under pressure.
Requires the ability to listen and interact effectively in order to identity and meet customer needs, provide instruction and explain policies.
Completes designated tasks within appropriate time and work with minimal supervision.
Requires 7 yrs experience, 1-3 years in a management capacity

Contact:
Judi Beachum, President/Owner
Abundant Resources, LLC
o - 615.353.9119
f - 615.356.9064
c - 615.604.3470
Judi@AbundantResources.net

Quality Assurance Analyst – TALX

2008-07-29T15:34:00.002-06:00

Position Summary:

This position develops test plans, creates test case scenarios, executes test programs, and works with development team members in implementing and improving quality standards and processes.

Responsibilities include:

reviewing functional and technical specifications to develop test plans and testing requirements checklists
performing testing, including system testing, regression testing, and stress/load testing
performing manual testing of interactive web and IVR applications, focusing on functional and end-to-end testing, validating that system response and output accurately reflect business requirements as outlined in requirements document
validating that data load processes operate properly and conform to standards, developing and executing volume/load test plans in order to provide predictable, high-quality software products
creating test data

Requirements

Preferred Skills / Experience:

a Bachelor's degree or 4 or more years related experience
two years experience in QA and testing within a software development environment, preferably with Internet technologies
must have experience with relational databases and be proficient using SQL
hands-on experience in testing complex business applications and understanding large complex environments, and knowledge of requirements-based testing
previous experience developing quality assurance methodologies and techniques
strong interpersonal capabilities along with solid verbal and written communication skills, and strong attention to detail, organization, decision-making, and self-administrative skills required
some programming experience is a plus

For further information, or to apply online, please visit:
http://talx.ats.hrsmart.com/cgi-bin/a/highlightjob.cgi?jobid=2260

TALX is an Equal Opportunity Employer M/F/D/V

Software QA/Testing Lead - Springfield, MO

2008-06-16T10:45:00.001-06:00

IIS is looking for a QA/Testing Lead who is willing to learn and work on new and innovative methods of testing and quality assurance. The ideal candidate should have 5-8 years of testing experience in mainframe and PC (web as well as client/server) environments. Familiarity with testing tools such as Rational Robot will be an added advantage.

Individual will be responsible for both QA and QC activities such as understanding, documenting and finding ways to improve testing processes; establish and help improve testing metrics; creating, updating, revising the test plans; creating test scripts using Rational Robot testing tool; review design documents and be able to develop test scenarios; be able to follow directions and defined process establish under QA activities.

Responsibilities

Understanding and documenting testing processes
Establishing and creating testing metrics
Creating and documenting test plans, test scenarios and test reports
Building the test environment
Testing of software on “mainframe” & “web-based” platforms
Investigation and replication of issues reported by customers
Logging issues in Issue tracking system
Automating the test scripts using Rational Robot
Guiding/training/mentoring the testers to perform one or more of the above responsibilities.

Candidates should be self-directed and possess strong leadership, communication and interpersonal skills, with proven effectiveness in both client and internal team interactions. An entrepreneurial spirit, a passion for delivering high quality products and a genuine commitment to our Living Company philosophy and flat management structure are essential. For more information, check out our website at http://www.iisfirst.com .

This position is located in Springfield, MO and is full-time with full benefits.

Intelligent Information Systems (IIS) is a 15-year-old software transformation company headquartered in Research Triangle Park, North Carolina. Please send resumes to HR1@iisfirst.com.

Assistant Plant Manager/Lean Coordinator - St. Louis

2008-06-16T10:43:00.001-06:00

The Gund Company is one of the nation's largest fabricator/distributors of thermoset composite materials and we are currently looking for an Assistant Plant Manager/Lean Coordinator at our St. Louis, Missouri facility.

This individual will be responsible for managing and directing supervisors, hourly personnel through delegation, coaching, and team leadership on the second shift. Main hours (Mon-Fri 1 pm - 10:30 pm), Saturday as necessary.

Duties

Review and suggest process improvements to ensure good manufacturing practices are followed.
Implement lean manufacturing practices.
Analyze variances to goals and develop action plans and countermeasures to correct shortfalls.
Manage planning function to meet production and forecast labor and material costs.

Job Qualifications

B.S. Industrial Engineering with 3-5 years of supervisory experience in a high speed manufacturing operation.
Knowledge of Quality Concepts (i.e. SPC, TQM, JIT) and Quality Systems (i.e. Six Sigma)
Knowledge of standard shop equipment (i.e. CNC, punch press, etc).
Well-organized, self-starter who is self-motivated with excellent communication skills and a strong sense of urgency, PC skills, including experience using MS Word, Outlook, Excel Problem solving and analytical skills.
Must be able to work well in a team environment.
Ability to communicate effectively with both your supervisor and shop floor personnel to understand assignments and to provide process-related feedback.
Experience with world class manufacturing techniques helpful.

Pay & Benefits
Medical Insurance, Dental Insurance, Life Insurance, Disability Insurance, 401K, Tuition Assistance, Bonus.

Contact Name: Deborah Denson
Phone: 314-423-5200
E-mail: ddenson@thegundcompany.com
Fax: 314-423-9009
Website: www.thegundcompany.com

Deadline for resumes – July 07, 2008

Senior Performance Engineer - St. Joseph, MO

2008-06-16T10:40:00.002-06:00

Position available with Premier, Inc.: "Sr. Performance Engineer" (Sr. Healthcare Industrial Engineer) with a large hospital St. Joseph, MO:

Please call Amanda Edwards, 704-649-3011 or email: Amanda_Edwards@Premierinc.com if interested in learning more!

Premier, Inc. is a healthcare alliance entirely owned by more than 200 of the nation's leading not-for-profit healthcare systems who operate over 1,500 hospitals and 41,000 other healthcare sites nationally. Premier's focus is to help these facilities accelerate performance both operationally and clinically while improving supply chain costs ultimately resulting in the delivery of improved healthcare to the communities they serve.

One way that we are able to affect these changes is to have a Performance Engineer based in our hospitals.

A Performance Engineer is a "change agent" for process improvement both in operational and clinical systems. Facilitating improvement in work processes most effectively through a team approach, the engineer leads the effort to document, review and improve operational and clinical processes. This effort should result in new work processes that minimize bottlenecks, reduce delays and improve the timeliness and quality of patient care. The engineer also can bring to the table "best practices" and help in the implementation of these more efficient processes. The engineer can also educate and motivate staff at all levels to objectively analyze their own work and simplify daily activities. The engineer is able to assist in the development of departmental labor budgets based on workload standards and volume projections and help managers understand how to more effectively staff according to the fluctuations in daily workload.

Manager, Medical Devices

2008-06-05T06:52:00.001-06:00

A global provider with long history in the imaging business, developing, manufacturing, and marketing products for hospitals, freestanding imaging centers and nuclear pharmacies is seeking a superstar candidate to manage the day to day processes and analysts responsible for handling complaints of medical devices.

Ensuring compliance with FDA regulations, FDA guidances and corporate procedures for complaint handling, MDR reporting and the providing of medical information by Product Monitoring (CPM). Develop, maintain and continually improve formats for organizing and publishing feedback from the field in ways which are relevant and useful to internal customers and corporate and site quality departments. Establish and maintain positive and mutually rewarding relationships with external and internal customers.

Essential Functions

Responsible for the day to day functioning of PM relative to medical device product complaint handling and the providing of medical information for medical devices.
Ensure compliance of PM with corporate level procedures for collecting, analyzing, trending, and reporting of post-market feedback reports globally.
Interface with Tech Service, Field Service (globally), Manufacturing, R&D, OUS QA/RA personnel to assure requirements are covered during investigation of complaints.
Participate in internal and external audits relative to Product Monitoring and Medical Information.
Direct the collection of all data necessary to provide monthly product field performance reports to Director Product Monitoring, corporate headquarters and other internal customers.
Determine workloads and create opportunities to improve efficiency and accuracy of complaint processing.
Provide approval and oversight for handling of phone and other contact from internal and external customers.
Develop and perform internal audits of complaint records and their supporting documentation to examine and assess compliance with applicable regulations, guidances and internal operating procedures. Present audit finding metrics in a meaningful way to Director, Product Monitoring. If necessary, make suggestions for corrective actions to processes and procedures when deficiencies in performance of PM personnel or adherence to operating procedures are noted. Archive audit findings and retrieve and disseminate findings when requested to do so.
Develop and perform internal audits of medical inquiry records of medical devices for compliance with applicable regulations, guidances and internal operating procedures. 10.
Present audit finding metrics in a meaningful way to Director, Product Monitoring. If necessary, makes suggestions for corrective actions to processes and procedures when deficiencies in performance of specialists or adherence to operating procedures are noted. Archive audit findings and retrieve and disseminate findings when requested to do so.
Identify, hire, train, develop and manage medical device product surveillance specialists.
Conduct training on Product Monitoring standard operating procedures for complaint handling and medical information functions for PM Staff as needed.
Conduct Post Marketing Surveillance training for company personnel out side of PM as called upon to do so.
Provide product performance expertise on cross-functional project teams as necessary.
Participate in teams concerned with development or support of products as necessary.

Qualifications

Education: Bachelor's degree in clinical field or other college degree with relevant experience.
Experience: A minimum of 5 years in the medical device industry preferably in a quality or regulatory role.
Thorough knowledge of FDA complaint & MDR reporting regulations required.
Knowledge of international regulations for complaint and vigilance reporting strongly preferred.

Preferred Skills

Previous managerial experience
Experience in the evaluation of medical literature and other scientific reports -Excellent verbal and written communication skills.
Experience in computer applications such as Microsoft Word, Excel, Access and Power Point.

Compensation and Benefits:

Very competitive plus comprehensive benefits package.

Contact

David Ruyle
888-282-5520
davidr@k2search.com

Quality Engineer - Essex Cryogenics of Missouri

2008-05-21T16:29:00.001-06:00

Job Summary
Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers, and regulatory agencies to implement Essex Cryogenics’ Quality goals.

Responsibilities

Perform Corrective and Preventive Action (CAPA) analysis, investigation, review and trending.
Resolve customer quality issues investigating returns and visiting customer as needed.
Review Engineering, Production and Quality documents to assure quality requirements are met.
Write DOT inspection reports.
Write quality procedures.
Write product regulatory plans based on FAA, FDA, DOT and ASME requirements.
Support, maintain and enhance the AS9100/ISO 9001:2000 Quality System, assuring organization adherence; promote system improvement via product Functional Configuration Audits and Physical Configuration Audits, process, supplier audits and Quality System audits.
Facilitate audits with AS9100/ISO 9001:2000 Registrar, Nadcap, FAA, FDA and customer auditors.
Assist in gathering quality data for monthly quality reports and bi-annual management reviews.
Aid production personnel in gathering and analyzing Statistical Process Control (SPC) data.
Perform miscellaneous tasks as defined by the Quality Assurance Manager.

Requirements

Quality Engineering experience.
Understanding of FDA Regulations, Code of Federal Regulations Tile 49 Transportation, ASME Boiler & Pressure Vessel Codes, Military Specifications and AS9100 Standard.
Knowledge of quality tools, sampling plans, problem solving, SPC, DOE, probability and statistics, metrology or inspection methods and equipment.

Education

B.S. Degree in Engineering or the equivalent of a degree as evidenced by an appropriate combination of formal education and related job experience.
American Society for Quality (ASQ) Certified Quality Engineer (CQE) and RABQSA Certified AS9100 Aerospace QMS Lead Auditor preferred or must be willing to work toward certifications.

Skills

Proficiency with Microsoft Office software: Word, Excel, Access, PowerPoint and Outlook.
Must have excellent written and oral communication skills.

Compliance Auditor - Aerotek

2008-05-19T16:24:00.001-06:00

Aerotek is looking for a Compliance Auditor to join our team.

Job Description
Looking for 5 people that have had experience in Quality and Compliance Auditing in a manufacturing plant environment. Any experience in a government or regulated environment is a bonus.

This opportunity is a 60-90 day contract in St. Louis, MO.

This is an immediate need. Please contact me at the information provided below.

Alicia Tedesco
Aerotek Scientific
Recruiter

Work: 314.819.1660
atedesco@aerotek.com

Quality Engineer – Medical Device

2008-04-26T13:41:00.000-06:00

The ideal candidate will possess a strong knowledge of process validation, FMEA/risk analysis, SPC, structured problem solving, and MS Access and Excel. Experience with error proofing, automated inspection techniques, and line layout / increasing work flow efficiency preferred. Software validation, LabVIEW, and sterile packaging experience is a plus. Associate’s Degree is required, Bachelor’s Degree preferred. ASQ certification is preferred.

Job responsibilities include implementing improvements in quality area to improve flow and efficiency of inspection process for new and existing product (including creating and identifying new test equipment); performing process validation on new equipment and processes; providing technical guidance to Manufacturing and Quality departments; supporting lean initiatives; identifying scrap/reject reduction opportunities and implementing reduction strategies; developing/improving/standardizing inspection procedures; participating in product validations, design reviews, and regulatory audits; and leading internal/external corrective action activities.

Please email your resume and salary requirements to humanresources@synergeticsusa.com for immediate consideration.

Principle Quality Assurnce Engineer

2008-04-26T13:18:00.000-06:00

OVERVIEW

My client is a Fortune 500 company that is dedicated to engineering, designing and manufacturing precision bearings for leading aerospace companies in North America, Europe and the Pacific Rim. Access to advanced materials, performance testing, product development and manufacturing technologies has led to superior solutions in the development and manufacture of ball and roller bearings for the latest engines and airframes.

Employing 600 people at its non-union plant in Central NH, the company is generating revenues of approximately $100 million per annum and the parent employs 26,000 people worldwide with $4.5 billion in revenues. The company is envisioning significant growth within the global aerospace market over the next decade. This position plays a key role to chartering that path of success with the goal of identifying and resolving quality issues and the implementation of continuous improvement objectives.

POSITION DESCRIPTION

The Principal Quality Assurance Engineer is a hands-on, shop floor, continuous improvement position. Business is so up, this plant is overbooked and they need to get better at what they do. Success in this role will lead to unlimited career advancement.

Specific responsibilities include:

Participating in a cross functional area teams (Star Team) in the resolution of quality issues in support of team objectives including (but not limited to) on time delivery goals, past-due reduction goals, scrap reduction goals, etc.
Supporting Continuous Improvement activities utilizing Process Capability studies, Machine Capability studies, Gage R & R studies and other statistical problem solving tools by gathering and interpreting data.
Implementing Operator Certification programs within assigned areas, including assessing, training, and mentoring the operators.
Supervising Inspection personnel within assigned departments.
Utilizing 8D techniques to investigate root cause analysis and perform effective positive corrective action.
Leading Lean Six Sigma teams, Kaizen events, and other progressive efforts.

CANDIDATE QUALIFICATION CRITERIA

Education/Certification
BSME or some other suitable technical discipline is required.
American Society of Quality – Certified Quality Engineer designation preferred.

Experience

5+ years of experience within a Quality discipline is required, preferably within precision metal fabrication.
Possessive of comprehensive working knowledge of an ISO 9001-2000 Quality Management System, AS 9100 requirements, SPC systems, metrology, and failure root cause analysis/corrective action.
Possessive of strong experience with the practical applications of Lean Manufacturing/Continuous Improvement methodologies (i.e., Six Sigma, Kaizen, Set-up reduction, waste reduction, etc.) and techniques ( i.e., Poke Yoke, Demand Flow, Pull systems, 5s)
Having a working knowledge of product inspection methods and techniques including hand-held gauging and other special gauging measurement techniques
Prior experience in bearings manufacturing, the design of tooling or gauging, and with hands-on inspection are all preferred, although not required

Personal Characteristics and Traits

An effective communicator, both externally with clients/suppliers and internally with peers and supervisors; able to communicate on a technical level with shop floor and production personnel as well as others within the organization.
Someone who is passionate about quality, able to strongly defend his/her position yet open to other viewpoints
Possessive of a strong professional demeanor, founded upon integrity and honesty
Having a high energy level with a strong work ethic.

Compensation

Base salary dependent upon experience; additional compensation includes incentive bonus (potential up to 10% of base salary). Very strong benefit package. Full relocation assistance provided.

Interested Candidates Please Email your resume in a word document.

Kate Brandt - Executive Recruiter
Management Search, Inc.
111 Founders Plaza, Suite 1400
East Hartford, CT 06108
P: 860.761.3248
F: 860.291.8495
kbrandt@msi1.com
www.msi1.com

Senior Quality Engineer - Colorado Springs

2008-04-07T22:29:00.001-06:00

Company Profile:

Spectranetics Corporation engages in the development, manufacture, marketing, and distribution of single-use medical devices used in minimally invasive surgical procedures within the cardiovascular system in the United States, Europe and Japan. Spectranetics Corporation was founded in 1984 and is based in Colorado Springs, Colorado.

Job Summary:

Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet requirements established by Spectranetics, customers and regulatory agencies. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives. Provides focused quality engineering support within new product development.
Maintains Risk Management documentation and provides Quality Engineering support for the life cycle of all Spectranetics products.

Education/Preferred Experience:

BS in Mechanical Engineering, Biomedical Engineering, Process Engineering or related technical discipline.
Strong and solid experience in Risk Management for medical devices
Application and leading problem-solving, root cause analysis and related Corrective and Preventive Action (including verification)
Experience with Health Hazard Analysis
Familiarity with ISO 14971
Medical devices engineering

Job Duties:

Provide QA leadership to project and system for the fill lifecycle of the product, service or system
Develop, update and maintain SOPs, forms, methods related to Quality in the NPI/DC SOP and Risk Management system
Ensure Risk Management is effective utilizing feedback from validation, field safety, manufacturing indicators, CAPAs, HHAs, ect.
Lead and support Health Hazard Analysis to ensure risk assessment and root cause analysis across products and systems.

Pleas submit resume to: julianne.mashke@spectranetics.com

Quality Control / Environmental Technician

2008-03-07T16:15:00.002-06:00

Industrial metal coatings company has an immediate opening for a Quality Control / Environmental Technician. This is a key position that reports directly to the Quality Manager.

Duties include, but are not limited to:
QC inspections, metals testing & evaluation, gage R&R studies, gage calibration control, environmental sampling/reporting, ISO internal auditing, maintaining QC lab equipment, and technical report writing. Will also provide assistance to process development engineers, interface with customers, and maintain lab procedures and documents.

Position involves reading and understanding technical drawings, specifications, work orders, and quality standards, such as AS9100, ISO 9001, FAA rules, and assisting with company compliance to federal, state, and city environmental regulations. Experience with magnetic particle inspection will be a plus.

Position requires diligence in following procedures, ability to work a flexible schedule w/overtime, excellent communication & organizational skills, multi-tasking, and accurate, detailed & high quality work.

Ideal candidate will have an Associates degree in quality control or engineering technology, and QC and/or environmental experience in a metals processing or heavy industrial environment.

Required skills are:

High school diploma/GED, (Associates degree preferred)
Microsoft Word & Excel proficiency
Excellent communication and organizational skills
Ability to work in an industrial environment

If you are interested in this position, you may contact Emily Ellerbusch at
(314) 421-7546 or eellerbusch@nooter.com

Quality Assurance Specialist (Medical Device)

2008-03-03T16:47:00.001-06:00

Rapidly growing ISO 13485:2003 Certified Medical Device developer and manufacturer in St. Louis, Missouri is seeking a Quality Assurance Specialist with experience in multi-discipline device design and improvement. We are looking for an aggressive and experienced person to fill a new critical role in the organization. The candidate will be responsible for developing and implementing a compliant quality management system in a fast paced, team environment. The successful candidate must have experience in Quality Management Systems for the Medical Device industry, product inspection and testing, training and support for the organization in compliance matters.

Duties and Responsibilities

Developing, implementing and improving overall quality systems, including quality standards, test methods, process control techniques, and reviewing documents such as Work Instructions, Quality Assurance Specifications, Final Inspection Instructions, protocols and reports to ensure safety, reliability and efficacy of products, processes and significant changes related to existing medical devices.

Evaluate design quality, monitoring, qualification, validation and trouble shooting activities. This will encompass:
1. product configuration control to assess the effects on materials compatibility, manufacturing processing and product physical properties;
2. change control, validation and verification;
3. defect corrective action process (investigation of performance issues on existing products)

Perform inspection and testing on incoming, in process and finished products. Maintain the Complaint system, files, database, etc. Complaint processing may require customer contact regarding complaint information and resolution. Responsible for the document control function, updating databases, maintaining controlled copies, etc.

This position will be responsible for tracking and preparing reports on Quality System metrics.

Education and/or Experience

Two year college degree or equivalent education and experience and a minimum of 5 years related experience in Quality Assurance/regulatory affairs in the Medical Device industry.

A complete and thorough understanding of the FDA QSR Regulations (21 CFR Parts 820), ISO 13485:2003 and ISO 14971 is required.

Working knowledge of SPC, DOE, Probability and Statistics, Metrology or inspection methods and equipment, quality information systems and product inspection, testing and release experience.

Experience with sterile products is a plus.

Certificates, Licenses, Registrations

ASQ CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) preferred

The strength of any company and its products is dependent upon the creativity, quality, and caliber of its employees. Envisioneering Medical Technologies offers exciting opportunities in the growing medical device industry.

To apply, visit monster.com and search for Envisioneering.

Quality Engineer - Synergetics

2008-02-28T16:07:00.004-06:00

Synergetics is a growing designer, manufacturer, and distributor of microsurgical instruments and capital equipment used primarily in vitreoretinal surgery and neurosurgical applications. We are seeking a Quality Engineer to support our electromechanical capital equipment product line.

The ideal candidate will possess a strong knowledge of IEC 60601 Electrical Safety Standards and proficiency in FMEA/risk analysis, CAPA, structured problem solving, and MS Access and Excel. Experience with error proofing, automated inspection techniques, line layout / increasing work flow efficiency, RF devices, and EMC testing is preferred. Software validation experience and ASQ certification is a plus. Associate’s Degree is required, Bachelor’s Degree preferred.

Job responsibilities include implementing improvements in Capital Equipment area to improve flow and efficiency of inspection for new and existing product; developing/improving/standardizing inspection procedures; participating in product validations, design reviews, and regulatory audits; performing process validation on new equipment/processes; serving as key contact on customer quality issues; providing technical guidance to Manufacturing and Quality departments; supporting lean initiatives; and identifying scrap/reject reduction opportunities and implementing reduction strategies.

Please email your resume and salary requirements to humanresources@synergeticsusa.com for immediate consideration.

Faculty Position - University of Houston

2008-02-22T11:25:00.000-06:00

The Department of Industrial Engineering at the University of Houston invites applications for an Assistant/Associate Professor Tenure Track position in Bioinformatics, Biomedical, and Health Care Systems Design and Management beginning Fall 2008. A doctorate in industrial engineering or closely related field is required.

The Department of Industrial Engineering grants BS, MSIE, MIE, and Ph.D. degrees and is one of the five departments in the Cullen College of Engineering. With over six decades of history and 150 graduate students, the Department has one of the largest graduate programs in the State. The City of Houston is the fourth largest and one of the fastest growing cities in the country. Several departments in the College have extensive research collaboration in biomedical engineering. The University also enjoys strong ties with the Texas Medical Center in the city, which is one of the largest medical centers in the world, and is uniquely positioned to provide opportunities to candidates to develop a strong research and academic relationship with the medical community.

We highly encourage candidates with strong research and teaching interests in the above referenced areas who can contribute to excellence of the Department and College's strategic goals to apply.

Interested applicants should provide a letter of interest, curriculum vita, and a minimum of three letters of recommendation. Materials (electronic submissions are preferred) should be submitted to:

Dr. Suresh Khator
Professor of Industrial Engineering and
Chair of the Faculty Search Committee
Department of Industrial engineering
University of Houston
E206, Engineering Building 2
Houston, Texas 77204-4008
Email: search@ie.uh.edu

Review of applications will start March 15 and will continue until the position is filled.

The University of Houston is an EEO/Affirmative Action Employer. Minorities, women, veterans, and persons with disabilities are encouraged to apply.

Assistant Professor - University of Massachusetts, Amherst

2008-02-22T10:37:00.000-06:00

THE University of Massachusetts - Amherst invites applications for a tenure-track position at the Assistant Professor level in the Department of Mechanical and Industrial Engineering in the area of Industrial Engineering and Operations Research. A Ph.D. degree in Industrial Engineering, Operations Research, or a closely related field is required. We especially encourage candidates with interests in Healthcare Systems including Medicine, Biology and Bioinformatics and Systems or Services Engineering.

Faculty members are expected to develop a strong sponsored research program, mentor graduate students and contribute to the teaching and learning experience of undergraduate and graduate students.

The University of Massachusetts Amherst is situated ninety miles west of Boston in the vicinity of four vibrant liberal arts colleges in a region offering exceptional and diverse cultural and recreational opportunities.

Applicants should, in a single PDF file, provide a statement of their teaching and research interests, curriculum vitae, names of at least four persons who may be contacted regarding the candidateʼs qualifications and a brief abstract for a seminar to be presented if invited for an interview. The department, with twenty four full-time faculty members (three female, two Hispanic) has a strong commitment to diversity and welcomes applications from women and candidates from other minority groups. Review of applications will begin March 3, 2008 and continue until suitable candidates are identified.

Applications preferred by email: ie_search@ecs.umass.edu

Mail:
Chair, IE Faculty Search Committee
Department of Mechanical and Industrial Engineering
University of Massachusetts
160 Governors Drive
Amherst, MA 01003-9265

The University of Massachusetts is an Affirmative Action/Equal Opportunity Employer

Women and Members of Minority Groups are Encouraged to Apply