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

Supplier Quality Engineer Position Summary

The Supplier Quality Engineer (SQE) supports supplier quality activities across both New Product Introduction (NPI) and sustaining manufacturing operations within a regulated medical device environment. This role ensures supplier compliance to applicable requirements, including 21 CFR Part 820 and ISO 13485, and contributes to supplier qualification, development, monitoring, and performance management activities.

Supplier Qualification & NPI Support

• Support supplier qualification activities for New Product Introduction (NPI) projects
• Conduct supplier assessments in accordance with established risk-based procedures
• Support supplier selection activities in collaboration with Engineering, Procurement, and Quality
• Participate in supplier audits (remote and onsite) as part of qualification and surveillance activities
• Review supplier documentation including certifications, quality records, and validation evidence
• Support supplier readiness activities for production launch, including process and quality system evaluations
• Participate in design transfer and process validation activities involving suppliers

Sustaining Supplier Quality Management

• Support supplier quality oversight for assigned NPI projects and production suppliers
• Monitor supplier performance using quality metrics (e.g., SCARs, defects, delivery performance)
• Support supplier corrective action activities (SCAR/CAPA) and ensure timely closure
• Conduct supplier performance reviews and drive continuous improvement initiatives
• Support containment, root cause analysis, and resolution of supplier-related quality issues
• Perform risk-based supplier re-evaluations and periodic assessments

Supplier Quality System & Compliance

• Ensure supplier compliance with applicable regulatory and quality system requirements including ISO 13485
• Maintain and improve Approved Supplier List (ASL) classification and risk-based controls
• Support external and internal audits involving supplier quality systems
• Ensure supplier quality agreements are established and maintained
• Drive adherence to change notification and supplier control requirements

Cross-Functional Collaboration

• Partner with Design Authority (customer), Procurement, Manufacturing and Engineering
• Support material nonconformance investigations and disposition decisions
• Provide supplier risk input to project teams and change control processes
• Support supply continuity and risk mitigation strategies

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.
• 1-3 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
• Understanding of quality systems and regulatory expectations (21 CFR Part 820, ISO 13485)
• Exposure to supplier quality, manufacturing, or inspection processes preferred
• Experience supporting NPI, manufacturing, or engineering projects a plus
• Preferred Certifications ISO 13485 Internal Auditor certification (or willingness to obtain). ASQ certifications (CQE, CQA, or similar) are a plus.