Supplier Quality Engineer

Manchester, NH

Full Time

Quality

Mid Level

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.

The SQE serves as a key interface between Engineering, Procurement, Quality, and the supplier base, supporting the assurance that suppliers consistently meet defined quality, regulatory, and performance expectations. This role supports supplier qualification activities for NPI programs, including onboarding of new suppliers, documentation review, and participation in process validation and design transfer activities. The SQE also supports sustaining supplier quality activities for production materials and services, including monitoring supplier performance and supporting resolution of supplier-related quality issues.

How you will make an impact as a Supplier Quality Engineer:

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

Skills you will need to be successful as a Supplier Quality Engineer:

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

Skills & Competencies

Good analytical and problem-solving skills
Ability to work effectively in cross-functional teams

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