Sr Supplier Quality Engineer

Endologix • Santa Rosa, CA

6d • $110,000 - $127,500 • Hybrid

About The Position

We're looking for a Sr. Supplier Quality Engineer to join our Quality team. The Sr. Supplier Quality Engineer (SQE) is 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 Sr. SQE serves as a technical leader and subject matter expert responsible for end-to-end supplier quality strategy, governance, and risk management across the product lifecycle in a regulated medical device environment.

Requirements

• Bachelor’s degree in Engineering, math or related discipline; Master’s degree preferred.
• Minimum of 5+ 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.
• Demonstrated leadership in: Supplier qualification, development, and risk management programs
• Process validation strategy (IQ/OQ/PQ/PPQ) and statistical methods
• Supplier change management and regulatory impact assessments
• 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 certification is a strong plus.

Responsibilities

• Lead supplier identification, qualification, maintenance, and ongoing monitoring activities to ensure suppliers consistently meet quality, reliability, and compliance expectations that ultimately support positive patient outcomes.
• Own and manage the Approved Supplier List (ASL) and Approved Component List (ACL), ensuring accuracy, transparency, and alignment with quality system requirements.
• Drive the implementation and assessment of supplier-related change orders, utilizing sound judgment and risk-based decision-making to support continuous advancement and operational excellence.
• Review and approve supplier changes, deviations, and documentation to ensure compliance with internal procedures, regulatory requirements, and the highest quality standards.
• Lead supplier Corrective and Preventive Actions (CAPAs) and Supplier Corrective Action Requests (SCARs), conducting thorough root cause investigations and implementing sustainable solutions that strengthen supplier performance.
• Investigate supplier-related nonconformances and quality issues, partnering with cross-functional stakeholders to implement effective containment, corrective actions, and risk mitigation strategies.
• Support Material Review Board (MRB) activities, nonconforming material disposition decisions, and failure investigations to ensure timely resolution of issues while maintaining product quality and supply continuity.
• Own supplier performance governance, including scorecards, business reviews, performance metrics, and escalation processes that promote accountability, transparency, and continuous improvement.
• Develop, review, and maintain high-quality technical documentation, including procedures, reports, justifications, and quality records, ensuring accuracy, clarity, and regulatory compliance.
• Collaborate closely with Engineering, Manufacturing, Regulatory Affairs, Supply Chain, Operations, and external suppliers to solve complex challenges, drive innovation, and deliver exceptional results.
• Lead supplier audits, including preparation, execution, follow-up, and remediation activities, fostering strong supplier partnerships while ensuring adherence to quality and regulatory expectations.
• Apply project management principles to effectively manage competing priorities, timelines, and deliverables in a dynamic and evolving environment.
• Champion continuous improvement initiatives by identifying opportunities to enhance supplier quality processes, systems, tools, and performance metrics.
• Demonstrate initiative, adaptability, and a willingness to challenge the status quo to drive meaningful improvements and advance organizational objectives.
• Perform other duties as assigned by management in support of departmental and organizational goals.

Benefits

• Competitive pay
• Solid benefits
• Career growth
• Culture that genuinely cares
• Flexibility
• Base salary of $110,000/yr-$127,500/yr
• 10% 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: Senior