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Senior Engineer, Quality

Round Lake, Illinois, US💼 Full-time💰 $96,000–$96,000🗓 2026-09-28 → 2026-10-01

Core

Senior Quality Engineer leading post-market risk assessments, failure analysis, and cross-functional quality reviews for therapeutic infusion products.

Role type

Senior IC Quality Engineer (Medical Devices)

Builds

Therapeutic infusion products and associated manufacturing/quality processes

Domain

Healthcare / Medical Devices / Regulated Manufacturing

Required skills

Post-market risk assessment, failure analysis, CAPA management, audit support, R&D quality support, NPD/SPO development, ISO quality systems, regulatory compliance

Preferred skills

Cross-functional team facilitation, problem solving in ambiguous situations, business/cost implication analysis

Technologies

ISO standards, Quality Management Systems (QMS)

Responsibilities

Lead post-market risk assessments of product issues; lead product performance investigations via failure analysis; participate in cross-functional Complaint, Change Control, and CAPA Review Boards; support readiness for internal/external audits; provide quality support to R&D and laboratory studies; define scope of quality deliverables for new product development

Seniority

Senior, hands-on IC

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