Medical Device Quality Assurance Engineer
USA, Texas, Austin On-site
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About the role
As a key member of the Quality Team you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes. As a key member of the Quality Assurance team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes. Utilizing comprehensive knowledge of engineering and problem-solving principles, this position is responsible for a variety of complex activities regarding the design, implementation, and maintenance of quality assurance procedures and work instructions to ensure external safety, quality, and compliance with complex Company standards and government regulations.
What you'll bring
- Bachelor’s in Science or Engineering with 3-5 years of experience OR 10-12 years of directly-related experience in a quality role..
- Experience with manufacturing transfers and validation (IQ/OQ/PQ) in a regulated environment required.
- Background in Medical Device, Aeronautics, Automotive or other highly regulated industry required
- Knowledge of technical writing quality and best practices.
- Required basic knowledge of manufacturing processes: key focus into metrology, precision machining, grinding, product cleaning, and sterilization.
- Individual should have knowledge of Microsoft Office Suite of software or equivalent.
- Preferred knowledge of the following software packages: Solidworks, Solidworks ePDM, Oracle R12, Agile PLM.
- Prefer CQE, Lean, or 6 Sigma Certification
- Accurate and professional telephone communication
- Accurate and professional written communication (email, text and formal letter)
- Position is office based (Austin, TX)
- Must be able to bend, twist and lift overhead.