Senior Quality Engineer - Mechanical/biomedical Degree
Manpower Professional (Sacramento, California)
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Our client is looking for a Senior Quality Engineer that will facilitate FMEA (Failure Modes and Effects Analysis) and problem solving techniques including root cause analysis and cause and effect analysis as they relate to customer field returns. ¿ Lead Corrective and Preventive Action¿s (CAPAs) as they relate to customer complaints/feedback from initiation through implementation. ¿ Lead quality initiatives by developing, evaluating, revising, troubleshooting, and applying technical quality assurance protocols and methods to inspect and test incoming, in-process, and finished product. ¿ Ensure suppliers deliver quality parts, materials, and services by using statistics and other quality tools to monitor and improve our incoming, in-process, and finished product processes. ¿ Ensure company activities are in compliance with company and government standards (FDA Quality System Regulation 21 CFR 820, ISO 13485:2003, EN, MDD, Canadian, UL and CSA regulations). ¿ Candidate must have a minimum of 7 years of medical device experience. (MUST be device or disposables not software) ¿ Experience in writing and executing engineering test protocols ¿ Experience in Corrective Action/Preventative Action (CAPA) ¿ Experience in Risk Analysis Techniques (FMEA, FTA) ¿ Process Excellence (Six Sigma) and/or ASQ certifications is preferred ¿ Blue print reading and interpretation including Geometric Dimensioning and Tolerancing (GD&T) is preferred Knowledge of: ISO 13485:2003, QSR Section 820, Standard statistical principles, theories, concepts, and techniques, Failure investigations in a manufacturing environment Job Title: Senior Quality Engineer - Mechanical/BioMedical Degree Primary Skills: ¿ Excellent prioritization, communication and leadership skills ¿ Proficiency with Microsoft Office suite ¿ Ability to understand business implications related to projects and opportunities ¿ To read and understand regulatory, quality and requirements documents in order to apply to manufacturing and quality systems. ¿ To determine essential components of requirements in order to include them in applicable quality engineering policies and procedures. Industry: Biomedical/Pharmaceutical Vacancies: 1 Job City: Sacramento Job Metro Area: Sacramento, CA Job State: CA Job Country: US Salary: Depends On Experience Hours per Week: Full Time Job Duration: Direct Placement Duration Detail: Degree Type: Bachelor of Science Degree Area: Experience Minimum: 7 years Certification/Licenses: To apply for this Professional.Jobs@manpower.com opportunity, please email your resume to: Professional.Jobs@manpower.com as an attachment in .doc., .pdf, .rft, .txt, .htm or .html file type only. Please include 94161/MB/NX849792 in the subject line of your email.
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