Staff Supplier QA Engineer – Lead CM Transfers | Equity

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

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.