Supplier Quality Engineer

Primis; Bedford (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Primis in Bedford, MA is seeking a Supplier Quality Engineer / Manufacturing Engineer for a 1-year contract. The role involves supporting process validation and verification across a large supplier base for catheter and console products, with travel up to 20% to supplier sites across the US.

The ideal candidate will have 6+ years in engineering, hands-on IQ/OQ/PQ, and experience with plastic, metal, and electronics components. Location options include Bedford, CO Springs, CO or Plymouth, MN.

Qualifications

• Bachelor's degree in engineering; Master’s a plus.
• 6+ years engineering experience with quality-focused roles.
• Hands-on IQ/OQ/PQ and process validation experience.
• Experience across plastics, metals, and electronics commodities.

Responsibilities

• Perform Process Validation, Verification, and TMV per APQP.
• Support supplier qualification including audits and Q agreements.
• Lead problem solving on FAI and APQP failures.
• Investigate defects and drive corrective actions via SCAR.
• Collaborate on DFMEA/PFMEA with R&D and QA.
• Provide oversight on supplier change requests and validations.
• Develop process validation plans and continuous improvement with suppliers.

Skills

IQ/OQ/PQ execution

Supplier quality

Cross-functional collaboration

Education

Bachelor's degree in engineering

Master's degree preferred

Tools

APQP

SCAR process

DFMEA/PFMEA

Job description

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

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