Quality Assurance Director

Working with a global leader in in vitro diagnostics the San Diego Director of QA will play a critical role in creating targeted content that reaches health care providers to show case how our products can improve the lives of their patients. 

Who are you? You will oversee the development, implementation and maintenance of quality assurance systems and activities. Oversee generation and review of documents used in good manufacturing practices. Also monitors audits of production and quality control areas. May audit raw material vendors and prepare manufacturing documentation for updated filing. Coordinates interdepartmental activities. May lead investigations and resolve potential product quality issues to improve efficiency. Selects, develops and evaluates personnel to ensure the efficient operation of the function.

To be successful in this role, you should preferably have 10+ years of experience in the IVD (reagent and/or instrumentation) industry. You should have thorough knowledge of FDA QSR, ISO 13485, and MDSAP. Have strong experience in Firmware, Hardware, and Software Engineering. You should also have experience supporting the realization of new products through new product development, third party manufacturers, and/or mergers and acquisitions, including oversight of Design Controls.