QUALITY TECHNICIAN II

DescriptionBiosense Webster, Inc (BWI), a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Tech II, 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 Tech II, under general supervision, participates in New Product Development teams 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) and other worldwide regulatory agencies pertaining to medical devices. This individual supports production floor activities (IQ/OQ/PQ) and product quality investigations. Work is well defined and is checked for progress and reviewed for accuracy upon completion. Primary responsibilities include assisting in a supporting role on new product development projects. The Quality Tech II assists in the development of effective quality control and associated risk management plans. Writes 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). Assists in Failure Mode and Effects Analysis activities for both Design and Process FMEA's. Helps to ensure 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. Assists in the 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 actions. Initiates and investigates Corrective and Preventative Actions (CAPA) as appropriate. Assists in complaint analysis as appropriate. Moderate exercise of judgment is required on details of work and in making selections and adaptations of engineering alternatives. Receives general direction on new aspects of assignments. Performs work which involves conventional types of plans, investigations, surveys, structures, or equipment with relatively few complex features for which there are precedents. Specifies inspection and testing methodologies, mechanisms, and equipment. Recommends revision of specifications to the NPD team. 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 Company regulations, policies, and procedures. Performs other duties assigned as needed.QualificationsAn Associate's degree and a minimum of 6 years of work experience, or a Bachelor's degree and a minimum of 4 years of work experience is required. Knowledge of Quality and Operations systems and processes, including GMP and QSR requirements for medical devices is required. American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is preferred. Knowledge of Quality Engineering, design control, and verification and validation (V&V) tools and methodologies is preferred. Proficiency i