Supplier Quality Engineer
$103,000–$163,000 year
On-siteBedford, Massachusetts, United States
Job Summary
Coordinate and execute supplier improvement initiatives, managing the Approved Supplier List and negotiating Supplier Quality Agreements. Provide sustaining SQE activities by managing daily NCRs, SCARs, and SCNs, while conducting detailed defect analysis to determine supplier-caused issues. Manage APQP with selected suppliers and facilitate technical capability assessments for potential new suppliers. Proactively monitor product/process quality trends, troubleshoot production/release issues, and oversee equipment qualification and process validation plans. Serve as an internal and supplier quality auditor, managing planning, execution, reporting, and closure of audits. Drive supplier improvement and corrective actions based on process/product trends, customer complaints, and regulatory requirements.
Required Qualifications
- 5+ years' experience in Supplier Quality Engineering within FDA regulated medical device environments
- focus on supplier selection
- performance assessment
- APQP
- Risk Assessments/PFMEA's
- SPC
- SCAR's
- SICR
- CAPA
- Remediation
- detailed knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820
- ISO 13485
- ISO 14971
- European Medical Device Directive (93/42/EEC)
- EU Medical Device Regulation
- Canadian Medical Devices Regulation (SOR/98-282)
- proven experience utilizing data analytics/KPI's to assess supplier performance and identify/drive process improvement opportunities
- strong communications skills
- proven ability to effectively communicate, influence and build relationships cross-functionally with a variety of internal/external stakeholders, suppliers, Regulatory Agencies, Notified Bodies etc
- minimum of a Bachelor's Degree (Required) in Quality, Engineering, or related disciplines
- minimum Physical, Cognitive and Environmental job requirements with or without accommodation
- Office-based role
- working in-person at least 3 days per week
- US work authorization
- no sponsorship for a work-authorized visa
- reside in or within commuting distance to Bedford, MA
- travel up to 10%
Desired Qualifications
- ASQ and/or Six Sigma DfX Certifications
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