PERMANENT, $60-75K Salary **NEGOTIABLE**

Attention medical device professionals! Kforce has a HOT opportunity for a Scientific Quality Assurance professional to oversee Quality auditing within an established pharmaceutical manufacturing and research company.

The candidate will be responsible for all aspects of QA including review of manufacturing records, internal and external auditing, corrective actions and follow up, drafting policies and procedures for internal quality programs, and have superior knowledge of quality systems. Candidate will also be responsible for investigation of customer complaints (internal and external). Experience working with R&D and QC in relation to new products for commercialization is required. Strong knowledge of sterile and terminal medical products is also required.

Qualified candidates will have:

• Minimum of a Bachelors Degree in a scientific discipline.
• 5+ years of Quality Assurance experience in the medical device REQUIRED. This includes experience with 21 CFR parts 11, 210, 211, and 820 as well as ISO and ICH. GLP experience is a plus.
• Experience with aseptic manufacturing
• Exceptionally strong oral and written communication.
• ASQ CQA certification is a plus.

Relocation will be offered for this position, so qualified non-local candidates are encouraged to apply!

Are you interested? Apply today by sending a copy of your resume by email or fax! Do you know of anyone that may be interested? PASS IT ON!

Contact Information:
Kforce Scientific Staffing
Attn: Jessica Duffey, Account Manager
622 Emerson - Suite 350
St. Louis, MO 63141
(314) 212-8731 (P)
(314) 995-5311 (F)

jduffey@kforce.com

www.kforce.com/scientific

Mid-America Transplant Services is expanding!

We’re looking for candidates with a bachelor’s degree, strong computer skills, and the ability to communicate with all levels within the organization. Process orientated thinking is a must!

Proficiency in Crystal Reports or other writing software. Competence in working with SQL databases is a plus. One to two years experience utilizing quality tools including: process improvement, lean manufacturing principles, six sigma methodology, FOCUS PDSA’s, Pareto charts, cause/effect diagrams, and value stream mapping is preferred.

MTS offers a competitive salary and a work environment 2^nd to none. We are an organization committed to our cause and our employees.

To apply please mail your resume to:
MTS; Attn: HR, 1139 Olivette Executive Parkway, St. Louis, MO 63132
or stop by to fill out an application.

To learn more about our organization, visit www.mts-stl.org

We save lives through excellence in organ & tissue donation!

Job Type: Permanent

Job Location: St. Louis, MO

Job Description:

Develop and execute software test plans, identify and facilitate issue resolution with team, and document test results. Provide team leadership for various.

Primary responsibility is to direct the testing of software changes originating from upgrades and new software development for an assigned group of products. These tasks will be both long-term and short-term in nature and conform to product upgrade cycles and new software implementation schedules. A thorough knowledge of testing methodologies and software development life cycles is required.

Required Skills:

• 4-6 years of experience testing web-based applications
• Experience with qa automated testing tools
• Training in and experience with Quality Assurance methods, standards, and tools
• Understanding of the Software Development Life Cyle
• Experience in a telecom, ISP, or cable industry preferred
  

Key Functions:

• Plan and execute testing of new systems, system and environment enhancements and upgrades, and defect resolution activities to verify that systems function according to user requirements and conform to established guidelines.
• Review system requirements and design specifications and provide feedback on testability.
• Use provided specifications, and other relevant architectural and system-level documentation, to create manual and automated test artifacts for system, integration, regression, and performance testing; perform peer reviews of test artifacts as required.
• Execute manual and automated test artifacts; document and report defects from test execution.
• Assist in performing defect root-cause analysis and recommend corrections.
• Report on status of testing activities as defined in the test plan and/or required by the test management process.
• Provide written analysis of test results regarding system readiness for promotion to the production environment.
• Provide timely feedback regarding testing issues and concerns.
• Participate in continuous quality improvement of established testing processes, practices, and standards.
  

Technical Skills:

• 3+ years PHP/ASP/HTML, 3+ years of MYSQL ORACLE (testing and/or development).
• Web Application Development (HTML/CSS, Perl, JavaScript).
• 2+ years of experience with Rational or Mercury automated test management and execution tools.
• Demonstrated experience supporting enterprise applications, particularly telecommunications adjunct systems.
  

Contact Information:
Mail Jaya Singh at jsingh@fastsearch1.com

Job Location: St. Louis MO

Job Type: Permanent

I. SCOPE OF POSITION

Encourage a business-enabling Quality culture throughout the organization. Develops, implements, and coordinates product assurance program to prevent or eliminate defects in new or existing products by performing the following duties personally or through subordinate supervisors.

II. PRINCIPAL DUTIES AND RESPONSIBILITIES

• Analyzes, evaluates, and presents information concerning factors such as business situations, production capabilities, manufacturing problems, economic trends, and design and development of new products for consideration by other members of management team.
• Proactively organize and promote opportunities for continuous quality improvement.
• Suggests and debates alternative methods and procedures in formulating and establishing company policies, operating procedures, and goals,
• Develops initial and subsequent modifications of product assurance program to delineate areas of responsibility, personnel requirements, and operational procedures within program.
• Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures.
• Develop and maintain working relationships with our suppliers and partners to ensure conformance to requirements.
• Confers with engineers about quality assurance of new products designed and manufactured products on market to rectify problems.
• Leverage quality data to assist New Business Development in growth of Business.
• Manage a 10-15 employee staff of Quality Engineers, Supplier Quality Engineers, Configuration management and Quality Technicians.

III. MINIMUM REQUIREMENTS

• BS in Quality Engineering, BSEE, or BSME.
• 5-10 years experience managing a Quality Assurance organization.
• 3-5 years experience implementing ISO Programs.
• Experience supporting quality objectives with international subcontractors. Preferably in the electronic component or PCB industry.
• Knowledge of Software Quality Assurance methodologies.
• Excellent verbal and written communication skills at all levels.
• Ability to travel up to 25% of the time.
• Experience with product failure analysis and reporting and the functioning and requirements of a reliability lab desirable.
• Spanish fluency a plus.

Contact Information: Mail Jaya at jsingh@fastsearch1.com

I. SCOPE OF POSITION

To plan, implement and monitor quality assurance activities to ensure product assurance to specifications and customer expectations. Provides leadership in problem solving techniques to effect corrective action and error prevention. This position focuses on participation on new product (RCE, SCE, SE, etc.) project teams.

II. PRINCIPAL DUTIES AND RESPONSIBILITIES

New Product Project Team Functions:

• Participates as a team member on new product project teams.
• Provides product project team updates to QA management.
• Participates in regularly scheduled and adhoc product project team meetings.
• Provide Project Engineer and other product project team members with Quality guidance.
• Ensures proper processes are being followed and identifies potential options when appropriate.
• Identify any potential product risks to the product project team and/or management.
• Review all documentation related to the product project.
• Participates in design reviews and compliance/product testing review of new products to ensure compliance to quality requirements of internal processes, external approval agencies and customers.
• FMEA facilitation as required.
• Statistical analysis as required.

Other Quality Functions:

• Either facilitates or is a member of the MRC (Material Review Committee).
• Creates or updates Quality Systems Procedures as required.
• Assists other departments with the creation of policies/procedures.
• Participates on Change Control Board (CCB) and/or Material Review Board (MRB) as required to assure objectives are met.
• Reviews Build to Print, Failure Analysis and First Article Reports as required.
• Performs or supervises the performance of quality audits as required.
• Responds to product returns by failure analysis, reporting and corrective action recommendations.
• Assists with the compliance and maintenance of DCSI’s Quality System Management System.
• Participates in DCSI’s compliance to ISO 9001:2000
• Issues CARs when appropriate
• Backup for supplier visits/qualifications
• Participates on and/or facilitates special teams (continuous improvement or other) as required.

III. MINIMUM REQUIREMENTS

• B.S/A.S. degree in Electrical Engineering, Industrial Engineering or Mechanical Engineering.
• Emphasis on mathematics or computer science desirable.
• ASQ Quality Engineer certification desirable.
• Five to eight years engineering experience in manufacturing or quality control in an electronic/electromechanical environment.
• Working knowledge in test equipment, measurement, statistical analysis and manufacturing processes.
• Working knowledge of statistical process control and experimental design concepts.
• Understanding of basic electronics, microprocessors, and integrated circuits.

Contact Information: Mail Jaya Singh at jsingh@fastsearch1.com

Position Summary:

ArborGen, LLC is seeking a seasoned Manager who has gained considerable working knowledge in quality, safety and compliance matters within a manufacturing, distribution, and R&D facility.

Quality Primary Functions:

• Responsible for plant product quality and customer satisfaction
• Lead all quality improvement activities (supplier, internal and customer)
• Manage and develop the quality system
• Responsible for audits and documentation requirements (internal, third party and customer)
• Train and develop staff in the use of quality tools and methodologies
• Manage and develop customer and supplier relationships
• Perform as resident expert in problem solving tools, process management, measurement
• Techniques and statistical analysis
• Maintain and report key quality metrics
• Champion continuous improvement activities plant wide
• Validate and assist in the development of verification and error proofing practices
• Interact closely with Regulatory Affairs Department
• Other duties as required to support the plant, and corporate quality initiatives

Compliance Primary Functions:

• Develop and manage audit program for regulatory compliance
• Oversight and upkeep of SOPs to meet compliance objectives
• Develop and oversee training programs in compliance activities and reporting

Safety Primary Functions:

• Develop, implement and maintain health and safety programs
• Develop and facilitate safety training
• Accident investigation and best management practices
• Partner with management to improve safety
• Manage monthly Safety committee
• Maintain paperwork in compliance with Federal Law
• Routing safety audits to ensure compliance while monitoring effectiveness of safety programs.

Certifications:

• Knowledge of ISO 9000 Quality Systems
• Certified Quality Auditor preferable

Education/Experience/Skills:

• 7 years of Quality and Safety Management experience
• Strong interpersonal and communication skills
• Bachelor’s Degree

Contact:

Adam Smith
Managing Director
Adam Smith Executive Search Consulting
Tel: (703)998-8118
Email: adamsmith@adamsmithsearch.com
http://www.adamsmithsearch.com/

Our client is a not for profit healthcare system in a very desirable, coastal area of Florida. This position will report to the COO and lead/facilitate systemwide organizational process improvement initiatives identified in the corporate Strategic Plan and PI Plan. The director will lead the development and implementation of improvement systems, enhancing clinical and non-clinical outcomes, patient throughput, core measures, etc. A Bachelor's Degree in education, business, nursing, organizational development, industrial engineering or related field and five years of management/leadership experience in a change agent role with a healthcare organization is required. A Master's Degree is highly desirable. Six Sigma Black Belt required. Expertise utilizing varied PI tools such as Lean Sigma, SPC, Simulation Modeling and other PI tools is highly desirable.

Competitive salary including potential bonus, excellent benefits and relocation package is available. Please submit current resume to robin@healthcarejobz.com