Senior Supplier Quality Engineer
On-site · Manchester, New Hampshire, United States
Job Summary
Lead supplier qualification activities for NPI projects and maintain sustaining supplier quality for production materials and services. Own supplier qualification, risk-based assessments, and audits (remote and onsite); review certifications, validations, and quality records; ensure readiness for production launch with capacity, quality systems, and process controls; support design transfer and process validation with supplier input; monitor supplier performance using quality metrics; drive supplier corrective actions (SCAR/CAPA) and continuous improvement; conduct risk-based re-evaluations and supplier risk management; collaborate with Design Authority, Procurement, Manufacturing, and Engineering; travel to suppliers up to ~20% as needed; ensure compliance with ISO 13485 and other regulatory requirements; maintain ASL classifications and support external/internal audits.
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or related technical field; or equivalent experience in regulated industry may be considered in lieu of degree
- 3–5 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
- Experience with supplier audits, qualification, and risk-based supplier management
- Experience supporting NPI or design transfer activities strongly preferred
- Strong understanding of manufacturing processes, validation, and quality systems
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