Staff Supplier Quality Engineer- Contract Manufacturing

Endologix LLC; Minneapolis (MN); On-site; USD 135,000 - 158,000; Full time

Benefits offered by this job

Equity participation

Health, dental, vision insurance

401(k) with company match

HSA/FSAs

Paid time off

Wellness programs

EAP

Job summary

Endologix LLC seeks a Staff Supplier Quality, CM to lead contract-manufacturer qualification, onboarding, and governance. This senior role partners with R&D, Design Assurance, and Manufacturing Engineering to ensure robust supplier controls, traceability, and regulatory compliance across transfers.

You will drive risk-based validation, CAPA, and supplier-change processes, while coordinating with internal teams to ensure production continuity and product quality for vascular therapies.

Qualifications

• Bachelor’s degree in Engineering or related technical discipline.
• Significant experience with contract manufacturers and manufacturing transfers.
• Experience within medical device quality systems (ISO 13485, FDA QMSR / 21 CFR Part 820).

Responsibilities

• Lead CM qualification, onboarding, governance, and ongoing oversight.
• Provide technical leadership for product, process, equipment transfers to CM.
• Partner with R&D and Design Assurance during development and changes.
• Establish CM quality oversight model with plans, agreements, and governance.
• Lead risk-based validation/transfer strategies including IQ/OQ/PQ/PPQ.

Skills

Contract manufacturing quality

Quality engineering leadership

Process validation

Risk-based problem solving

Regulatory compliance

Cross-functional collaboration

Education

Bachelor’s degree in Engineering

Master’s degree preferred

Tools

QAD

MasterControl

TrackWise

Job description

Overview

Join our innovative, mission-driven Quality team as a Staff Supplier Quality, CM at Endologix!

Overview

Join our innovative, mission-driven Quality team as a Staff Supplier Quality, CM at Endologix!

Who We Are

Endologix LLC is a California-based global medical device company dedicated to improving patients’ lives through innovative therapies for the interventional treatment of vascular disease. Our therapeutic portfolio addresses clinically relevant unmet needs, spanning from abdominal aortic aneurysms to lower limb peripheral vascular disease. We are committed to delivering excellent clinical outcomes through precision in product design, advanced manufacturing, and comprehensive physician training—supported by industry-leading clinical evidence. At Endologix, we’re driven by purpose, innovation, and the opportunity to make a lasting impact in vascular health.

What sets us apart is not just our technology, but our culture. At Endologix, we foster a forward-thinking, mission-driven environment where every team member plays a vital role in advancing patient care. Our core values guide how we operate. As for our people? We empower them with the tools, trust, and continuous learning they need to grow. If you’re passionate about making a meaningful difference in healthcare, you’ll find purpose and belonging here.

Our Core Values are the guiding principles informing our choices and actions, because our customers and patients depend on us:

• Patient Outcomes Drive Us: We improve lives with every advancement we deliver.
• Integrity Defines Us: We do what’s right, stay transparent, prioritize quality, and own our actions.
• Innovation Advances Us: We stay curious, adaptable, and push boundaries.
• Boldness Propels Us: We take smart risks and are unafraid in our pursuit of excellence.
• Collaboration Unites Us: We partner across teams and with physicians to drive exceptional results.

About The Role

The Staff Supplier Quality, CM is the senior individual-contributor technical lead for contract manufacturing quality and manufacturing transfer activities. This role establishes the quality controls, governance, and technical expectations required to qualify, transfer, scale, and sustain manufacturing at contract manufacturers in a regulated medical device environment. The Principal SQE partners closely with R&D, Design Assurance, Manufacturing Engineering, Operations, Regulatory Affairs, Supply Chain, and the Supplier Quality team to translate product and process requirements into robust supplier controls. The role serves as the engineering subject matter expert for complex supplier and contract manufacturer changes, providing technical leadership and influence without direct people-management responsibility.

Responsibilities

WHAT YOU'LL DO:

• Lead the quality workstream for contract manufacturer qualification, onboarding, governance, and ongoing oversight, ensuring controls are appropriate for product, process, patient, compliance, and continuity-of-supply risk while supporting consistent quality performance and reliable product availability.
• Provide technical quality leadership for product, process, equipment, tooling, test method, facility, and manufacturing-site transfers to contract manufacturers, including transfer planning, readiness assessments, risk reviews, execution, and post-transfer stabilization, ensuring seamless collaboration and successful implementation across internal and external stakeholders.
• Partner with R&D and Design Assurance during development and design changes to ensure supplier capability, manufacturability, critical requirements, risk controls, verification needs, and transfer requirements are defined early and translated into effective and sustainable supplier controls.
• Establish and maintain the contract manufacturer quality oversight model, including quality plans, quality agreements, responsibility matrices, escalation pathways, performance reviews, and governance routines that encourage accountability, transparency, and strong cross-functional partnerships.
• Lead risk-based process validation and transfer strategies, including IQ/OQ/PQ or PPQ, validation master planning, protocol and report review, statistical rationale, acceptance criteria, and maintenance of the validated state to ensure product quality, process reliability, and regulatory compliance.
• Assess and approve complex contract manufacturer and supplier changes, deviations, concessions, and implementation plans, ensuring technical, quality-system, risk-management, and regulatory impacts are identified, evaluated, and addressed prior to execution.
• Define and implement risk-based receiving, in-process, release, traceability, monitoring, and supplier‑evidence controls, with clear linkage to specifications, drawings, critical‑to‑quality characteristics, process risks, and product risk‑management documentation to support product integrity and patient safety.
• Lead technical problem solving for significant supplier and contract manufacturer nonconformances, investigations, CAPAs, and SCARs using data‑driven root cause analysis, effective containment, sustainable corrective actions, and effectiveness verification to prevent recurrence and drive continuous improvement.
• Provide engineering leadership for supplier process capability, measurement‑system analysis, test‑method validation, inspection strategy, control plans, sampling, SPC, and ongoing process‑performance monitoring, leveraging technical expertise and data insights to enhance quality and operational performance.
• Lead contract manufacturer quality readiness for product launches, capacity expansion, new equipment, line moves, automation, and major process changes, including the definition and closure of quality deliverables and readiness gaps to ensure successful execution and business continuity.
• Partner with Supplier Quality team members to standardize contract manufacturer controls, strengthen technical capability, provide guidance on complex engineering challenges, and ensure consistent execution across suppliers while fostering collaboration and knowledge sharing.
• Lead or provide technical support for contract manufacturer audits, process assessments, technical reviews, business reviews, and supplier escalations; ensure remediation plans are risk‑based, sustainable, and effectively implemented to strengthen long‑term performance and compliance.
• Develop, review, and approve high‑quality technical and quality documentation, including transfer plans, validation strategies, quality plans, risk assessments, change assessments, engineering justifications, procedures, reports, and quality records that support clarity, traceability, and inspection readiness.
• Apply strong project management practices to coordinate cross‑functional workstreams, decisions, dependencies, risks, timelines, and deliverables across internal teams and external manufacturing partners, driving alignment, execution excellence, and achievement of shared objectives.
• Identify systemic opportunities to enhance contract manufacturing governance, transfer execution, supplier controls, process capability, and prevention of recurring quality issues through innovation, continuous learning, and proactive improvement initiatives. Perform other duties as assigned in support of organizational goals and the delivery of safe, effective, and high‑quality products for patients.

Qualifications

WHAT YOU'LL BRING:

Education

• Bachelor’s degree in Engineering or a related technical discipline; Master’s degree preferred.

Experience

• Minimum of 10 years of progressive experience in Supplier Quality, Quality Engineering, Manufacturing Engineering, Process Engineering, or a related role, including significant experience supporting contract manufacturers and manufacturing transfers.
• Demonstrated experience working within a medical device quality system and applicable requirements, including ISO 13485, FDA QMSR / 21 CFR Part 820, and risk management principles.
• Demonstrated experience leading complex, cross‑functional product or manufacturing transfers, contract manufacturer qualification, process validation, and supplier change implementation.
• Demonstrated success influencing technical and business decisions across internal engineering teams and external manufacturing partners without direct authority.

Skills/Competencies

Required:

• Deep technical knowledge of contract manufacturer lifecycle controls, supplier qualification, supplier development, quality agreements, performance governance, and risk‑based oversight.
• Demonstrated technical leadership in:
  • Product and manufacturing transfer planning, readiness, execution, and stabilization
  • Process validation strategy (IQ/OQ/PQ/PPQ), process capability, statistical methods, sampling, SPC, and measurement systems
  • Design-change and supplier-change implementation, including technical, quality, risk‑management, and regulatory impact assessment
• Ability to interpret drawings, specifications, process documentation, validation evidence, risk‑management files, and manufacturing data to define appropriate controls.
• Advanced problem‑solving capability, including complex investigations, root cause analysis, CAPA, SCAR, containment, and effectiveness verification.
• Ability to establish practical controls and decision gates that protect product quality while enabling transfer, scale‑up, and supply continuity.
• Excellent technical writing, communication, facilitation, and executive‑level presentation skills.
• Strong cross‑functional leadership and ability to build effective partnerships with R&D, Design Assurance, Manufacturing Engineering, Operations, Regulatory Affairs, Supply Chain, and external manufacturers.
• Advanced project‑management skills with the ability to lead multiple complex workstreams, manage ambiguity, and drive timely decisions and deliverables.
• Experience leading supplier or contract manufacturer audits and technical process assessments.
• Willingness to travel domestically and internationally for contract manufacturer transfers, qualification, audits, issue resolution, and governance activities.

Preferred

• Experience with sterile or implantable medical devices, external manufacturing networks, and global manufacturing transfers highly desired.
• ASQ Certified Quality Engineer, Six Sigma certification, or ISO 13485 Lead Auditor certification is a strong plus; experience with QAD, MasterControl, or TrackWise is preferred.

What We Offer

At Endologix, we know that great work starts with great people - and people do their best when they feel valued and supported. That’s why we offer competitive pay, solid benefits, career growth, a culture that genuinely cares, and the flexibility you need to thrive both at work and at home. But more than that, we offer purpose. You’ll be part of a team that’s making a real impact on patients’ lives. When you join us, you’re not just taking a job, you’re building a meaningful career with a team that’s invested in your success.

The Compensation Package Includes

• Base Salary of $135,000-$157,500/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

Plus

• Employee wellness initiatives, mental health resources, and Employee Assistance Program (EAP)
• Employee recognition programs and awards
• Commuter benefits or transportation stipends

Our Commitment To Equal Opportunity And Veteran Inclusion

Endologix LLC is an Equal Opportunity and Affi- All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law. As a federal contractor, Endologix LLC is committed to taking affirmative action to recruit, employ, and advance in employment qualified individuals with disabilities and protected veterans.