Senior Supplier Quality Engineer - Contract Manufacturing

Endologix; Minneapolis (MN); Híbrido; USD 135 000 - 158 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

401(k) with company match

Equity participation

Resumo da oferta

Endologix is seeking a Staff Supplier Quality Engineer - Contract Manufacturing. You will be the senior technical lead for supplier quality and manufacturing transfers at contract manufacturers, establishing controls and governance in a regulated medical device environment.

You will collaborate with R&D, Design Assurance, Regulatory, and Supply Chain to translate requirements into robust supplier controls, driving quality and supply continuity.

Qualificações

• Bachelor’s degree in Engineering or related technical discipline; Master’s degree preferred.
• Min 10 years in supplier quality or related roles with contract manufacturing experience.
• Experience in a medical device quality system (ISO 13485, FDA QMSR/21 CFR Part 820).
• Leads complex product/ manufacturing transfers and supplier changes.

Responsabilidades

• Lead CM qualification, onboarding, governance, and oversight for product quality.
• Provide technical leadership for transfers, including readiness assessments and stabilization.
• Partner with R&D and Design Assurance on development changes and supplier controls.
• Establish CM quality oversight model, plans, agreements, and governance routines.
• Lead risk-based process validations, IQ/OQ/PQ/PPQ strategies and approvals.
• Assess and approve supplier changes, deviations, CAPAs, and SCARs.
• Define receiving, in-process, release, traceability controls linked to specs.
• Lead investigations and corrective actions for supplier/nonconformances.
• Provide engineering leadership for process capability, SPC, and testing.
• Prepare for product launches, capacity changes, and line moves with quality deliverables.

Conhecimentos

Contract manufacturing

Quality leadership

Risk-based oversight

Cross-functional collaboration

Technical problem solving

Formação académica

Bachelors in Engineering

Master's degree preferred

Ferramentas

TrackWise

MasterControl

QAD

Descrição da oferta de emprego

Endologix is seeking a Staff Supplier Quality Engineer - Contract Manufacturing. You will be the senior technical lead for supplier quality and manufacturing transfers at contract manufacturers, establishing controls and governance in a regulated medical device environment.

You will collaborate with R&D, Design Assurance, Regulatory, and Supply Chain to translate requirements into robust supplier controls, driving quality and supply continuity.