- Manage quality engineers
- Identify and resolve issues in the manufacturing of Class III medical device
- Oversee the Material Review Board (MRB),
- Review and approve validations (IQ/OQ/PQ
- Conduct, manage all audits for ISO and FDA
- Manage CAPAs and Audit Action Plans
- Represent the Quality function in corporate and site meetings.
- B.S Degree in Engineering required or bachelor’s degree in technical area, Master’s Degree preferred.
- 5 years within medical device industry