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Senior Quality Engineer

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Reference Number: MD-1828104224
Date Posted: 11-01-21
Location: Mid Atlantic

Our client is a biotechnology company in the Mid Atlantic with a revolutionary product. They are seeking a Senior Quality Engineer to join their team.

What's in it for you...
  • Ground floor opportunity
  • Diversity in the role
  • High visibility
  • Be part of the company build - joining at exciting time
  • Great opportunity to touch everything
  • Exciting technology
To be considered for an interview, the following experience/skills are desired:
  • BS degree in Engineering (Chemical, Mechanical, Biomedical, etc.)
  • 5+ years quality engineering experience in the medical device industry
  • Experience in the development, implementation, maintenance and ongoing support of the QMS including document creation and updates to SOPs, forms, and work instructions
  • Demonstrated proficiency with Quality System procedures and Medical Device Directives, 21 CFR 820 and ISO 13485, and related international standards
  • Experience in supporting both manufacturing and product development efforts, including process development, assay design, qualifications and verifications/validations
  • Experience writing protocols, performing CAPA, systematic problem solving and scaling up manufacturing operations
If you experience technical difficulties when applying to this position, please email your resume directly to MedicalDeviceTeam@MRIGlobalMedDevice.com