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We have an immediate need for a Quality Engineer for a cutting-edge client in the pharmaceutical industry! The ideal candidate is someone who is experienced, hardworking, and knowledgeable of medical device regulations and standards. This candidate will have the pleasure of joining a premium team of talented engineers and analytical minds.
Required / Desired:
• 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 Pharma and/or Medical Device Industries.
• EDMS (Electronic Change Control Systems) knowledge.
• Solid Technical Writing skills w/ SOPs, Work Instructions, Technical Reports, FMEA’s, etc…
• Experience with updating risk-assessments based on product complaint data processing.
• MS Word, MS Excel, MS Outlook, VISIO – Proficiency.
• Great communication skills – verbal, written, and with graphical techniques.
• Effective working in a cross-functional group.
• The type of QE who takes good notes in meetings.
• 7-10+ years of experience working in Pharmaceutical or Medical Device industries, in a quality department role.
• BS in Engineering or Sciences, or equivalent combination of education and experience would be considered.
• 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.
• Support pre-market design and development programs – secondary function.
• Design and develop combination-products and related regulatory requirements governing human-use and commercialization.
o 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.
Are you available? Please send your most current resume to Leonard at firstname.lastname@example.org
Please reference JO#16565LJ
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.
We specialize in Information Technology, Technical Sales and Marketing Staffing on a Contract, Contract to Hire, and Direct Hire basis.
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