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Our Client is seeking a Quality Engineer with Medical Device or Pharmaceutical Company experience for an extendable 6-month contract in Novato, CA.
• Help manage a combination of products (medical/pharma devices) post-market activities, which include – Risk Management, product complaints, adverse events, quarterly system management review, annual product review, and assessment of impacts from the evolving regulatory landscape to product line documentation.
• All types of documentation and writing, including taking great notes in meetings, and transforming those notes into team-action.
• Support pre-market design and development programs.
• Design and develop combination-products and related regulatory requirements governing human-use and commercialization.
? Support pre-market activities in the design and development of combination products.
• Organize, analyze, and report on quality metrics for market products that contain device components and assemblies.
• Perform required post-market risk-management activity to maintain risk profiles and associated controls for all device products.
• Periodic assessment of regulatory requirements against marketed products and associated controlled documents.
• Facilitate revisions to SOPs as required, to support the current state of business.
• Perhaps work into a QE role.
• 7-10 years of experience as a Quality Engineer in a Medical Device or Pharmaceutical company.
• Solid understanding of the Life Cycle of Product Development within a Medical Device or Pharmaceutical company environment.
• Risk Management experience.
• Solid understanding of the Complaints loop within a Medical Device or Pharmaceutical company and Risk-assessments knowledge based on product complaint data processing.
• Broad range of knowledge and experience with the design and development of combination-products and the regulatory requirements governing human-use and commercialization.
• FDA knowledge (standards, methodologies).
• Experience working with Quality Management Systems, specifically CFR Title 21 Part 820.
• ISO 13485 knowledge.
• Proficient with GxP practices in the Medical Device or Pharmaceutical Industries.
• EDMS (Electronic Change Control Systems) knowledge including ECO’s, ECN’s, ECR’s, etc.
• Solid Technical Writing skills w/ SOPs, Work Instructions, Technical Reports, FMEA’s, etc.
• Experience with updating risk-assessments based on product complaint data processing.
• Technical writing skills w/ SOPs, Work Instructions, Technical Reports, FMEA’s, etc.
• Proficiency with MS Word, MS Excel, MS Outlook, VISIO.
• Great communication skills – verbal, written, and with graphical techniques.
• BS in Engineering or Sciences, or equivalent combination of education and experience.
Are you interested and available? Please send your current resume to Eric at firstname.lastname@example.org. Please reference JO# 16565EK
Mainz Brady Group provides technology staffing solutions to the best known companies in Software Development, Finance, Electronics/Manufacturing, Retail, R&D, Services, Biotechnology, Healthcare and Telecommunications.
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