Overview

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.

Requirments:

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

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Austin Vita is acting as an Employment Agency in relation to this vacancy.

Austin Vita is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.