Senior Quality Engineer
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Reference Number: MD-1828104224
Date Posted: 05-30-22
Location: Mid Atlantic
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
- 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