Job Description
The Quality Engineer – Systems supports Quality R&D activities for system and instrument product development by ensuring products are developed, tested, and transferred to manufacturing in compliance with FDA QSR, ISO 9001, ISO 13485, IVDR, MDSAP, and other applicable regulations. This role serves as a Quality subject matter expert for design controls, risk management, verification and validation, and product lifecycle management, partnering closely with R&D, program management, and cross‑functional teams to review and approve design documentation, maintain compliant Design History Files, and guide quality best practices across software, reagent, disposable, and full system development efforts. The position also supports post‑market activities, CAPA, audits, and inspections, identifies systemic process improvements, develops quality training, and helps ensure products remain safe, compliant, and state‑of‑the‑art throughout their lifecycle.

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