NPI & Compliance: Supplier Quality Engineer

Connexion Systems & Engineering Inc.; Bedford (NH); On-site; USD 70,000 - 90,000; Full time

Job summary

Connexion Systems & Engineering Inc. seeks a Supplier Quality Engineer to support NPI and sustaining manufacturing activities in a regulated medical device environment.

The role emphasizes supplier qualification, documentation review, and audits to ensure ISO 13485 and 21 CFR Part 820 compliance. Responsibilities include overseeing supplier performance, driving SCAR/CAPA actions, containment, and cross-functional collaboration with Design Authority, Procurement, Manufacturing and Engineering to

Qualifications

• Bachelor’s degree or equivalent experience in a regulated industry.
• 1-3 years of supplier quality or quality engineering experience in medical devices or regulated environments.
• Strong knowledge of ISO 13485 and 21 CFR Part 820.

Responsibilities

• Support supplier qualification and NPI activities in a regulated medical device setting.
• Monitor supplier performance and drive corrective actions (SCAR/CAPA).
• Assist in supplier audits (remote and onsite) and documentation reviews.
• Collaborate with Design Authority, Procurement, Manufacturing and Engineering.

Skills

Supplier quality

Quality engineering

Regulatory knowledge

Cross-functional collaboration

Problem solving

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

QMS software

Job description

Connexion Systems & Engineering Inc. seeks a Supplier Quality Engineer to support NPI and sustaining manufacturing activities in a regulated medical device environment.

The role emphasizes supplier qualification, documentation review, and audits to ensure ISO 13485 and 21 CFR Part 820 compliance. Responsibilities include overseeing supplier performance, driving SCAR/CAPA actions, containment, and cross-functional collaboration with Design Authority, Procurement, Manufacturing and Engineering to