Manager, Biological Quality Assurance Job in Menlo Park, California US
Manager, Biological Quality Assurance
Acclarent, Inc., a member of Johnson Johnson's Family of Companies, is recruiting for a Manager of Biological Quality Assurance, located in Menlo Park, CA. Acclarent, Inc. is a medical device company in Menlo Park, CA that was established in June of 2004. The company is dedicated to the development of innovative devices providing new technologies to further meet the needs of ENT patients. Acclarent's initial focus is on achieving the goals of sinus surgery with novel, endoscopic, catheter-based tools - Balloon Sinuplasty devices. Through the Balloon Sinuplasty technology and our Relieva product portfolio we offer ENT patients another option to conventional endoscopic surgical technologies. FDA clearances for these devices were completed in 2005 and the products were commercially launched in the US that same year. Through our core technologies and commitment to innovation, Acclarent will continue to advance novel devices in all areas of ENT. The Manager of Biological Quality Assurance (BQA) provides technical leadership and guidance regarding Biological Quality Assurance consisting of Environmental Controls, sterilization of single-use (EtO sterilization) and re-useable medical devices (steam sterilization, hydrogen peroxide, cleaning and disinfection etc). This individual provides support to product development teams by developing strategies for sterilization testing. They will also develop validation protocols and reports for new product qualification and coordinates testing with test laboratories. The Manager BQA will be responsible for all sterilization activities at Acclarent, will oversee activities at the sterilization suppliers and manage the supplier relationships. The incumbent supports the sterilization of New Product Development and will prepare necessary data for regulatory submissions. The incumbent will oversee environmental monitoring, microbiological testing and associated compliance requirements for manufacture of commercial products. They will ensure environmental monitoring, sterilization, biocompatibility and shelf life procedures are developed, implemented and maintained. The Manager, BQA establishes and reports Microbiology performance metrics and will report back to Acclarent Management. The individual will oversee related investigations/corrective actions, test failures, environmental monitoring and sterilization issues. This individual leads process / system improvements in the Quality Engineering area and will drive projects of major magnitude and scope using department resources. The Manager of Biological Quality Assurance may support other product development activities, such as biocompatibility and shelf life testing, as needed. The Manager BQA will develop plans and budgets for assigned projects. This position will have direct reports and will manage the sterilization supplier relationships.