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Supplier Quality Engineer
Job in
Fort Wayne, Allen County, Indiana, 46805, USA
Listed on 2026-03-03
Listing for:
Monica Burt & Associates
Full Time, Contract
position Listed on 2026-03-03
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer
Job Description & How to Apply Below
Job Description
Overview:
We are hiring an experienced Contract Supplier Quality Engineer to join our onsite team for a 12-month orthopaedic medical device manufacturing transfer project (spine preferred). This role will be central in ensuring supplier processes meet stringent medical device quality standards through validation, control plans, and measurement system analyses.
Key Responsibilities:
- Drive supplier quality engineering activities during manufacturing transfer of orthopedic devices
- Lead process validation (IQ, OQ, PQ) and establish robust supplier control plans
- Perform MSA & GR&R at supplier sites to ensure system reliability
- Collaborate with suppliers, engineering, and quality teams to ensure smooth transfer and compliance
- Required onsite full-time in Fort Wayne, IN
Qualifications:
- 6 to 10 years' experience in supplier quality engineering within the orthopedic medical device industry (spine preferred)
- Proven success with manufacturing transfers, validations, and quality systems
- Strong background in MSA & GR&R methodologies
- Required onsite full-time in Fort Wayne, IN
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