The Quality Systems Engineer (PMS) will be responsible for ensuring compliance of the QSR to all applicable regulations and standards & working cross-functionally with various teams to execute the transition EU Medical Device Directive to EU Medical Device Regulation.
- B.S., Life Science, Engineering, or related
- Minimum 2-4 years experience in a highly regulated Medical Device space
- Strong experience with applicable medical device regulations such as EU MDR, 21 CFR 820, ISO 13485:2016, ISO 14971:2019 and MDSAP
- Proficient in Microsoft Office suite, SPC tools
- Excellent planning, collaboration, and communication skills
- Attention to detail & ability to work in a fast paced environment
- Lead auditor experience preferred