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Quality Engineer

Quality Engineer Develop, implement and maintain Quality Assurance Engineering programs on assigned areas in labs and Manufacturing.
Provide quality engineering support and approval of test method validations, verification and validation strategies, activities, protocols, reports, etc.
Participate in the development of quality plans and supporting documents for new medical device products, including notified body audits / FDA audits.
Develop inspection programs and methods for new components, assemblies and finished products and instruct quality control technicians.
Provide quality engineering support and approval of test method validations, verification and validation strategies, activities, protocols, reports, etc.
Use statistical tools (Minitab, etc.
) to analyze data, make acceptance decisions, and improve process capability.
Experience with FMEA & Risk Management.
Experience with process validation protocols and reports (IQ/OQ/PQ).
Experience performing risk analysis, root cause analysis; developing a corrective action plan, implementing the plan.
This position requires 2 to 25 years' medical device manufacturing experience.
Knowledge of medical device regulations such as ISO 13485, 21CFR 820, etc.
ASQ Certified Quality Engineer.
Excellent interpersonal and communication skills.
This position requires a B.
S.
Mechanical, Biomedical, Materials and/or related engineering degree.
Master's degree preferred.
Key Words:
Quality Engineering, Medical Device, regulations ISO 13485, 21 CFR 820, CAPA, Validation, Lab experience.
Desired degrees and schools:
M.
S.
Mechanical Engineer, MIT, University of Pennsylvania, Cornell, Harvard, Brown, Duke, Villanova, Drexel, Penn State, Carnegie Mellon, University of Mass, University of Illinois Urbana Champaign, University of Michigan, Purdue University, Virginia Tech, University of Maryland College Park.
If interested & you meet the requirements please send a copy of your resume as a word doc attachment to email removed .
Steve Moore direct line 484 567 2081.
Code:
liberty123

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