QA Engineer – Medical Devices & IVD Manufacturer, Los Angeles, CA
QA Engineer needed to manage the selection, qualification, and monitoring of suppliers including finished device, OEM, and contract manufacturers. This person will play a key role in working with suppliers to resolve quality issues (SCAPAs), resolving internal non-conforming product issues, addressing incoming inspection challenges, including development and review of inspection procedures, overseeing equipment calibration, maintenance and validation, and maintaining accurate and complete documentation of these activities in compliance with the requirements of the Quality System Regulation (21 CFR 820) and ISO 13485.
Requirements
- B.S. in in a technical discipline (i.e. science or engineering)
- Five or more years of relevant experience in an FDA regulated industry
- 3-5 years of which is in Quality Assurance
- ASQ Certification as Quality Engineer (CQE) or equivalent, preferred
