QUALITY ENGINEER

DescriptionBiosense Webster, Inc (BWI), a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Engineer, 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 Quality Engineer participate in New Product Development (NPD) teams and other activities to develop products, design verification tests, process validations and quality processes to ensure compliance with company Quality System policies, procedures, standards (FDA, ISO 13485, CMDCAS, PMDA), other worldwide regulatory agencies, and other applicable standards as they pertain to medical devices. This individual supports production floor activities (IQ/OQ/PQ) and product quality investigations. May receive technical guidance on complex problems, but independently determines and develops approaches and solutions. Shares technical expertise with others and helps develop junior level engineers. Primary responsibilities include working in Quality Engineering with other functional groups in support of new product development projects. The Quality Engineer 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 Failure Mode and Effects Analysis activities for both Design and Process FMEA's. Determines sterility, biological and packaging test requirements utilizing appropriate industry or agency standards for new products. Ensures that development activities follow design control requirements, product is tested per applicable standards, European Essential Requirements are met per the MDD, 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. Conducts vendor qualification assessments and participates in supplier selection as necessary. Participates in MRB review of nonconforming product; recommends disposition and corrective actions. Initiates and investigates Corrective and Preventative Actions (CAPA) as appropriate. Assists in complaint analysis as appropriate. 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 represents the organization in conferences to resolve important questions and to plan and coordinate work. Carries out assignments requiring the development of new or improved techniques or procedures. Develops new or improved techniques or procedures. Assesses the feasibility and soundness of proposed engineering evaluation tests, products, or equipment when necessary data are insufficient or confirmation by testing is advisable. Responsible for communicating business related issues or opportunities to next management level. Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition. Responsible for ensuring personal and Company compliance with all Federal, State, local and