MANAGER, QUALITY ENGINEERING

DescriptionBiosense Webster, Inc (BWI), a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Quality Engineering, to be located in Irwindale, California. Biosense Webster, Inc., is recognized worldwide as an industry leader in endocardial diagnostics and therapy. Guided by the needs of electrophysiologists and cardiologists, the company has pioneered innovative technological advancements ranging from the first deflectable tip catheter to today's most sophisticated three-dimensional cardiac mapping and navigation systems. Biosense Webster, Inc., combines leading-edge technology with a tradition of quality and responsiveness while partnering with the physician to optimize patient outcomes. The Manager, Quality Engineering plans, manages and coordinates quality engineering activities for New Product Development (NPD), manufacturing transfers, sustaining engineering and other related quality and compliance requirements to ensure effective processes are in place that are consistent with established standards by performing the following duties personally or through subordinates. Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, the Manager, Quality Engineering plans and directs resources and activities of Quality Engineers, Analysts and Technicians. Participates in project teams and company initiatives to assure compliance with Quality System requirements while achieving company objectives. Reviews, advises, participates and makes decisions related to non-conformances, CAPA, and internal audit issues. Supports production and release of internally and externally manufactured products and components. Acts as a technical liaison between Quality Engineering and other business functional organizations. Ensures that Quality Engineering resources are capable of providing required consultation and input for new projects, product development and transfer, manufacturing and distribution. Ensures that performance and quality of products conforms to established company and regulatory standards. Ensures quality requirements for transferring product from development to commercial production are met. Participates in cost reduction and improvement programs. Leads or supports the resolution of technical or operational problems. Manages and develops quality engineers, technicians, and inspectors. Works with other functional groups in support of new product development projects. Develops and establishes effective quality control and associated risk management plans. Writes, reviews and/or approves process and product validation protocols and reports, equipment qualifications, and engineering change orders. Uses statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE). Directs Design and Process Failure Mode and Effects Analysis (FMEA) activities. Ensures that development activities follow design control requirements, product is tested per applicable standard, and product is properly transferred to manufacturing. Provides all planning necessary to ensure effective product acceptance. This includes, but is not limited to, inspection instructions, equipment and gage requirements, and sampling plans. Participates in MRB review of nonconforming product; recommends disposition and corrective action. Assists in complaint analysis as needed. Assists Regulatory Affairs in developing submissions for new devices as necessary. Participates in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes. Makes decisions independently on engineering problems and methods, and represent Quality Engineering on the Project Investment Board (PIB) as needed. Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment when necessary data are insufficient or confirmation by test