Jobs in New Hampshire 2026 (Now Hiring) - Smart Auto Apply
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Supplier Quality Engineer
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Overview
Job Description
- Support supplier qualification activities for New Product Introduction (NPI) projects
- Conduct supplier assessments in accordance with established risk-based procedures
- Support supplier selection activities in collaboration with Engineering, Procurement, and Quality
- Participate in supplier audits (remote and onsite) as part of qualification and surveillance activities
- Review supplier documentation including certifications, quality records, and validation evidence
- Support supplier readiness activities for production launch, including process and quality system evaluations
- Participate in design transfer and process validation activities involving suppliers
- Support supplier quality oversight for assigned NPI projects and production suppliers
- Monitor supplier performance using quality metrics (e.g., SCARs, defects, delivery performance)
- Support supplier corrective action activities (SCAR/CAPA) and ensure timely closure
- Conduct supplier performance reviews and drive continuous improvement initiatives
- Support containment, root cause analysis, and resolution of supplier-related quality issues
- Perform risk-based supplier re-evaluations and periodic assessments
- Ensure supplier compliance with applicable regulatory and quality system requirements including ISO 13485
- Maintain and improve Approved Supplier List (ASL) classification and risk-based controls
- Support external and internal audits involving supplier quality systems
- Bachelors degree in Engineering, Life Sciences, or related technical field; or equivalent experience in regulated industry may be considered in lieu of degree.
- 1-3 years of experience in Supplier Quality, Quality Engineering, or related role in medical device or regulated industry
- Strong knowledge of ISO 13485 and medical device regulatory requirements
- Understanding of quality systems and regulatory expectations (21 CFR Part 820, ISO 13485)
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