Supplier Quality Engineer

Endologix • Santa Rosa, CA

8d • $90,000 - $102,500 • Hybrid

About The Position

We're looking for a Supplier Quality Engineer to join our Quality team. In this role, you'll be responsible for ensuring that purchased materials, components, and services meet defined quality, regulatory, and business requirements. This role partners closely with suppliers and internal cross‑functional teams to manage supplier performance, drive continuous improvement, and support product quality throughout the product lifecycle. The SQE plays a critical role in supplier management and development, change management and issue resolution in a regulated medical device environment.
Please note, this is not an entry-level position and is designed for an experienced, hands-on professional who can operate with a high degree of independence while continuing to build depth and expertise within supplier quality and regulatory practices.

Requirements

• Bachelor’s degree in Engineering, math or related discipline; Master’s degree preferred.
• Minimum of 3 years of experience in Supplier Quality, Quality Engineering, or a related role
• Experience working within a medical device quality system and applicable regulations (e.g., ISO 13485, FDA QSR).
• Demonstrated experience with supplier qualification and management, supplier development, and supplier monitoring.
• Experience in supporting or leading supplier‑related change management activities.
• Strong knowledge of ASL and ACL management and supplier lifecycle controls.
• Experience with change order processing and supplier change impact assessments.
• Working knowledge of PPAP and IQ/OQ/PQ validation techniques
• Solid understanding of CAPA methodologies, root cause analysis, and effectiveness checks.
• Experience leading SCARs and driving prompt, effective supplier corrective actions.
• Excellent technical writing skills with the ability to produce clear, concise, and compliant documentation.
• Strong cross‑functional collaboration and communication skills.
• Effective project management skills, including prioritization, planning, and execution.
• Supplier audit experience
• Willingness to travel domestically and internationally for supplier visits and audits.
• Ability to work independently, manage multiple workstreams, and meet deadlines in a fast‑paced environment.

Nice To Haves

• Experience with QAD, MasterControl or TrackWise highly desired
• ISO 13485 Lead Auditor capability is a strong plus.

Responsibilities

• Lead supplier identification, qualification, maintenance, and ongoing monitoring initiatives to ensure external partners consistently meet quality, regulatory, and performance expectations.
• Own and maintain the Approved Supplier List (ASL) and Approved Component List (ACL), ensuring records are accurate, complete, and aligned with quality system and regulatory requirements.
• Serve as the quality representative for supplier-related change orders, performing evaluations, impact assessments, and change order processing to safeguard product performance and patient safety.
• Review and approve supplier changes, deviations, and documentation to ensure transparency, regulatory compliance, and adherence to internal quality standards.
• Lead and manage supplier Corrective and Preventive Actions (CAPAs) and Supplier Corrective Action Requests (SCARs), facilitating root cause investigations, corrective action implementation, and effectiveness verification.
• Investigate supplier-related nonconformances and quality issues, coordinating containment actions, corrective measures, and risk assessments to prevent recurrence and protect product reliability.
• Support MRB activities, nonconforming material disposition, and failure investigations associated with outsourced products or services, ensuring timely and well-informed decisions.
• Develop, review, and maintain clear, high-quality technical documentation including procedures, reports, justifications, and quality records that support traceability, compliance, and operational excellence.
• Partner cross-functionally with Engineering, Manufacturing, Regulatory Affairs, Supply Chain, and Operations to maintain product quality and ensure uninterrupted supply of critical components.
• Support supplier audits through preparation, participation, and follow-up activities, working collaboratively with suppliers to address findings and strengthen quality systems.
• Apply structured project management practices to manage multiple initiatives, timelines, and deliverables while maintaining a high standard of execution.
• Drive continuous improvement of supplier quality processes, tools, and performance metrics to strengthen supplier partnerships and enhance overall product quality.
• Perform other duties as assigned by the supervisor in support of departmental and organizational objectives.

Benefits

• Base salary of $90,000/yr-$102,500/yr
• Discretionary bonus
• Equity participation as approved by Board of Directors (4-year vesting schedule)
• Comprehensive health, dental, and vision insurance plans
• Flexible Health Savings Accounts (HSAs) and/or Flexible Spending Accounts (FSAs)
• Generous paid time off (vacation, sick leave, holidays, and flexible time off that is available for Exempt employees)
• 401(k) retirement plan with company match
• Flexible work arrangements, such as hybrid or remote work for many of our positions
• Employee wellness initiatives, mental health resources, and Employee Assistance Program (EAP)
• Employee recognition programs and awards
• Commuter benefits or transportation stipends

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level