Supplier Quality Engineer
Job in
New Bedford, Bristol County, Massachusetts, 02746, USA
Listed on 2026-09-25
Listing for:
Intellectt Inc
Full Time
position Listed on 2026-09-25
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist -
Engineering
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Hiring a Supplier Quality Engineer with 5 to 8 years of hands‑on experience in the medical device industry. This role supports supplier‑facing quality activities as part of a UDI remediation project spanning ~600 SKUs of Class I medical devices.
Duties & Responsibilities:- Manage supplier qualification, audits, SCARs, NCRs, CAPAs, and supplier performance.
- Review supplier processes, inspection methods, specifications, and quality documentation.
- Support supplier PPAP/FAI, process validations, and change control activities.
- Investigate supplier‑related defects and drive root cause and corrective actions.
- Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and medical device quality systems.
- Partner with suppliers and internal teams to resolve quality issues and improve process capability.
- Bachelor’s degree in Engineering or related field.
- 5+ years of Supplier Quality experience in medical devices.
- Experience with SCAR, CAPA, NCR, FAI/PPAP, supplier audits, and root cause analysis.
- Strong knowledge of ISO 13485 and FDA 21 CFR 820.
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