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QUALITY ENGINEER II-8244130111
Biosense Webster, Inc (BWI), a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Engineer 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.
Under general supervision, participate 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 that pertain to medical devices. Support 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.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The listed requirements are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Primary responsibilities include assisting in a supporting role on new product development projects and sustaining engineering activites. The Quality Engineer II will assist in the development of effective quality control and associated risk management plans. Write process and product validation protocols and reports, equipment qualifications, engineering change orders. The Quality Engineer II will use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE), as well as assisting in Failure Mode and Effects Analysis activities for both Design and Process FMEA's. The Quality Engineer II will help 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. The resource will also assist in planning necessary to ensure effective product acceptance; this includes, but is not limited to: inspection instructions, equipment and gage requirements, and sampling plans. The Quality Engineer II will participate in MRB review of nonconforming product; recommend disposition and corrective action. The Quality Engineer II may initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate and assist in complaint analysis as appropriate.
This position requires moderate exercise of judgment is required on details of work and in making selections and adaptations of engineering alternatives. The Quality Engineer II Receives general direction on new aspects of assignments and performs work which involves conventional types of plans, investigations, surveys, structures, or equipment with relatively few complex features for which there are precedents. The Quality Engineer II may specify inspection and testing methodologies, mechanisms, and equipment and recommend revision of specifications to the NPD team.
BS in engineering, physical, biological, or natural sciences required, along with a minimum of 2-4 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry is required. Master's degree in an applicable field of study, along with a minimum of 1 years of related experience, is preferred.
An American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable. The ability to develop and implement Quality Standards is preferred. This role requires knowledge of Quality and operations systems and processes, including GMP and QSR requirements for medical devices. Knowledge of Quality Engineering, design control, and verification and validation (V&V) tools and methodologies is also required. The ability to apply project management skills to fulfill new product development requirements is (preferred, required Auditing and problem solving skills are required. Lean manufacturing experience is preferred. Some understanding of business and financial metrics is preferred. A basic understanding of theoretical and practical fundamentals and experimental engineering techniques is required.
This position requires an estimated travel of 5-10%, domestic and international. The Quality Engineer II must be competent using MS Office (word, excel, power point, outlook, etc), and have the ability to multi-task and manage multiple assignments in a time manner. The Quality Engineer II will must also have good verbal and written communication skills as well as strong interpersonal skills.
This position is located in Irwindale, California.
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Primary Location:North America-United States-California-Irwindale
Organization:Biosense Webster Inc. (6010)
Job: Quality (Eng)
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