Synergetics is a growing designer, manufacturer, and distributor of microsurgical instruments and capital equipment used primarily in vitreoretinal surgery and neurosurgical applications. We are currently seeking a Quality Engineer for our O’Fallon, Missouri facility.

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.

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:

1. 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.
2. 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.
3. Implementing Operator Certification programs within assigned areas, including assessing, training, and mentoring the operators.
4. Supervising Inspection personnel within assigned departments.
5. Utilizing 8D techniques to investigate root cause analysis and perform effective positive corrective action.
6. 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

1. 5+ years of experience within a Quality discipline is required, preferably within precision metal fabrication.
2. 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.
3. 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)
4. Having a working knowledge of product inspection methods and techniques including hand-held gauging and other special gauging measurement techniques
5. 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

1. 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.
2. Someone who is passionate about quality, able to strongly defend his/her position yet open to other viewpoints
3. Possessive of a strong professional demeanor, founded upon integrity and honesty
   
4. 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

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

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

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.

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.

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.