SR. QUALITY ENGINEER Job in Irwindale, California US
Biosense Webster, Inc (BWI), a member of Johnson Johnson's Family of Companies, is recruiting for a Senior Quality Engineer, 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 Senior Quality Engineer will participate in New Product Development (NPD) teams and other activities to develop products, conduct design verification tests, process validations, quality inspections and qualify processes to ensure compliance with company Quality System policies, procedures, standards (FDA, ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies), and other applicable standards as pertains to medical devices. This individual will support production floor activities (IQ/OQ/PQ) and product quality investigations. May need to provide technical guidance on complex problems, but independently determines and develops approaches and solutions. Shares technical expertise with others and helps develop junior level engineers.
The Senior Quality Engineer works in Quality Engineering 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 (Minitab, etc) 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 products; 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. Assesses the feasibility and soundness of proposed engineering evaluation tests, products, or equipment when necessary data are insufficient or confirmation by testing is advisable.
Qualifications
A Bachelor's degree and a minimum of 4 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry, or a Master's degree and a minimum of 3 years of related experience is required. A Bachelor's degree in engineering, physical, biological, or natural sciences is preferred. American Society for Quality (ASQ) certification is preferred. Six Sigma, Lean manufacturing, and/or Process Excellence experience is preferred. Thorough knowledge of Quality and operations systems and processes, including GMP and QSR requirements for medical devices is preferred. Thorough knowledge of leading edge Quality Engineering, design control, and verification and validation (VV) tools and methodologies is required. The ability to apply project management skills to ensure fulfillment of new product development requirements is preferred. Demonstrated auditing and problem solving skills are required. The ability to train and mentor a diverse array of employees on quality topics is preferred. Proficiency in the Microsoft Office suite of products (Word, Excel, PowerPoint, and Outlook) is required. The ability to multi-task and manage multiple assignments in a timely manner is required. Up to 10% international and domestic travel may be required. This position is located in Irwindale, California.
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