Supplier Quality Engineer

Supplier Quality Engineer / Manufacturing Engineer – Medical Device (Contract)

Location: Bedford, MA preferred (also considering Colorado Springs, CO or Plymouth, MN)

Contract: 1 year, renewable

Travel: Up to 20% to supplier sites across the US

A leading medical device manufacturer is looking for an experienced Supplier Quality Engineer, Manufacturing Engineer, or Product Quality Engineer to support process validation and verification across a large supplier base producing plastic, metal, and electronic components for a catheter and console (system) product line, covering 700+ parts.

What you'll do:

• Perform Process Validation, Verification, and Test Method Validation (TMV) per APQP requirements
• Support Supplier Qualification, including audits, Quality Agreements, and Change Notice Agreements
• Lead problem solving on First Article Inspection (FAI) and APQP failures
• Investigate defects and drive corrective actions through the SCAR process
• Collaborate with R&D and Quality/Design Assurance on Design for Manufacturability, DFMEA, and PFMEA
• Provide quality oversight on supplier-initiated change requests (SICRs), including regulatory review and validation
• Develop and oversee process validation plans, equipment qualifications, and continuous improvement initiatives with suppliers

What you'll need:

• Bachelor's degree in engineering (Master's a plus), 6+ years of engineering experience
• Hands-on subject matter expertise in IQ, OQ, PQ
• Experience across plastic, metal, and electronics commodities
• ISO 13485 Lead Auditor certification a plus

ADVERT DISCLAIMER

Research indicates that men will apply to a role when they only meet 50-60% of the descriptions, however, when looking at women and other minority groups, they can look for up to a 99% match in order to apply to a role. If you feel you are a fit for our role, please still apply, don’t worry if you don’t tick every single box. We’d still love to hear from you. We encourage underrepresented talent to apply to all our roles & support accessibility needs