Job Description
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
Requirements
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 systemsStrong background in MSA & GR&R methodologiesRequired onsite full-time in Fort Wayne, IN