Role OverviewJoin our Quality team as the Sr. Supplier Quality Engineer at Endologix! The Sr. Supplier Quality Engineer 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.
What You Will Do
Lead supplier identification, qualification, maintenance, and ongoing monitoring activities to ensure suppliers consistently meet quality, reliability, and compliance expectations. Own and manage the Approved Supplier List (ASL) and Approved Component List (ACL), drive the implementation and assessment of supplier-related change orders, and review and approve supplier changes, deviations, and documentation.
Why It Might Be a Fit
We're looking for a Sr. Supplier Quality Engineer to join our Quality team. The ideal candidate will have a strong knowledge of ASL and ACL management and supplier lifecycle controls, demonstrated leadership in supplier qualification, development, and risk management programs, and experience leading SCARs and driving prompt, effective supplier corrective actions.
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
Benefits
- 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
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