Location
Irvine, CA, United States
Posted
July 08, 2026
Job Description
Job Description
The Quality Engineering Manager will lead a team of quality engineers, technicians, and inspectors supporting the manufacturing of Class II/III medical devices. This individual will partner closely with Manufacturing, R&D, Regulatory Affairs, and Quality teams to drive process improvements, support new product introductions, and ensure compliance with quality system requirements. Responsibilities include overseeing validation activities (equipment, process, and test method), risk management initiatives, supplier quality and process control programs, CAPA investigations, customer complaint resolution, and manufacturing quality metrics. The manager will also support regulatory inspections and audits, maintain controlled quality documentation, drive continuous improvement efforts using statistical methodologies, and develop and mentor a growing quality team.
We are a company committed to creating diverse and inclusive environments where people can bring their f...
The Quality Engineering Manager will lead a team of quality engineers, technicians, and inspectors supporting the manufacturing of Class II/III medical devices. This individual will partner closely with Manufacturing, R&D, Regulatory Affairs, and Quality teams to drive process improvements, support new product introductions, and ensure compliance with quality system requirements. Responsibilities include overseeing validation activities (equipment, process, and test method), risk management initiatives, supplier quality and process control programs, CAPA investigations, customer complaint resolution, and manufacturing quality metrics. The manager will also support regulatory inspections and audits, maintain controlled quality documentation, drive continuous improvement efforts using statistical methodologies, and develop and mentor a growing quality team.
We are a company committed to creating diverse and inclusive environments where people can bring their f...