Principal Quality Engineer
Core
Lead the implementation, maintenance, and continuous improvement of the IVD Quality Management System (QMS) to ensure compliant product development and regulatory alignment for in vitro diagnostics and software-enabled medical devices.
Role type
Principal Quality Engineer (IVD Regulatory & Quality)
Builds
Scalable, risk-based QMS processes, procedures, and governance mechanisms for IVD and software-enabled IVD products.
Domain
Medical Devices / In Vitro Diagnostics (IVD) / Regulatory Compliance
Required skills
IVD QMS implementation, FDA quality-system requirements, ISO 13485, ISO 14971, IEC 62304, IEC 62366, risk management, design controls, supplier quality strategy, audit readiness, CAPA management, cross-functional leadership
Preferred skills
ASQ CQA certification, ISO 13485 Lead Auditor certification, Ketryx platform experience, advanced degree
Technologies
Ketryx, FDA-regulated compliance tools
Responsibilities
Lead QMS implementation roadmap and process prioritization; translate regulatory requirements into practical quality processes; serve as senior quality representative in product development and risk management forums; provide functional direction and coaching to quality personnel; review and approve critical quality-system procedures and CAPAs; establish and monitor QMS performance metrics; oversee supplier-quality strategy and execution; lead audit and inspection readiness activities; build a culture of quality and continuous improvement.
Seniority
Principal, hands-on IC with strategic oversight
