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
