Medical Device Supplier Quality Engineer (Contract)

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

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.