Senior Supplier Quality Engineer - Contract Manufacturing

Endologix

Minneapolis (MN)

On-site

USD 135,000 - 158,000

Full time

6 days ago

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Benefits offered by this job

Equity participation

401(k) with company match

Health, dental, and vision insurance

HSAs and/or FSAs

Generous paid time off

Commuter benefits

Job summary

Endologix is seeking a Staff Supplier Quality Engineer - Contract Manufacturing to lead quality for contract manufacturers, qualification, transfer, and governance. You will define supplier controls, risk management, and quality plans in a regulated medical device environment, partnering with R&D, Design Assurance, Regulatory, Supply Chain, and external manufacturers to enable safe, scalable production.

This senior individual contributor role emphasizes technical leadership, complex supplier

Qualifications

Bachelor’s degree in Engineering or a related technical field.
10+ years in Supplier Quality, Quality Engineering, or related roles in medical devices.
Experience with ISO 13485, FDA QMSR / 21 CFR Part 820, and risk management.
Proven cross-functional leadership without direct people management.

Responsibilities

Lead QA for contract manufacturers qualification, onboarding, governance, and oversight.
Plan transfers, risk reviews, and post-transfer stabilization across sites.
Define supplier controls, quality agreements, and escalation pathways.
Lead investigations, CAPAs, SCARs, and preventive actions with data-driven analysis.
Partner with R&D, Regulatory, and Supply Chain to enable scalable production.