6 results for Design Quality Engineer Jobs in Irvine, CA, US

Develop quality assurance documentation for new product development, support design control maintenance, engage in risk management activities, and complete design verification and validation reports. Conduct design reviews, establish inspection plans, and support product design transfers. Lead risk ...

Must Have Technical/Functional SkillsKnowledge on Quality Management and its tools & techniquesKnowledge about GMP (Good Manufacturing Practices), FDA, ISO 13485 and compliance regulationsKnowledge on Medical Device Regulatory Standards, MDD and MDRKnowledge on NC, CAPA, Root Cause Analysis and ...

The Bio-Rad Laboratories Design Quality Assurance team located in Irvine, CA, is seeking a detail oriented Design Quality Engineer to support the design, development and maintenance of life science and clinical diagnostics products. You will work closely with local and global cross functional team m...

Supports the design, development, and maintenance of life science and clinical diagnostics products. Collaborates with global cross-functional teams to ensure compliance with regulations, manages design control activities, facilitates risk management, oversees quality during product development, and...

Roles & Responsibilities 2-5 years of experience in a Quality Engineering or similar role within an FDA regulated industry preferably medical device and diagnostics that includes experience with CAPA and auditing processes. Participate in the governance, and execution of the Quality Management ...

Responsible for leading and supporting the design and development of medical devices, conducting risk analysis activities, applying statistical methods, developing test methods, and ensuring compliance with quality standards. Communicates cross-functionally and participates in audits while maintaini...