Senior Technician, QC/QA-7728120615
Hi-Tech meets Medical Devices at Biosense Webster! If you want to work with brilliant people in a fast paced environment, help make a huge difference in patient's lives and want to be responsible for providing the most innovative technology in the field of cardiac electrophysiology, then Biosense Webster is the place for you! Our vision and mission are clear - be #1 in rhythm solutions globally and cure AF (Atrial Fibrillation), the most common heart arrhythmia. Our products are used by prominent physicians around the world and help improve thousands of patient's lives. Simply put, we are a highly innovative entrepreneurial company with a truly global and diverse culture, backed with the support structure of the Johnson & Johnson Corporation - quite a winning combination! Our commitment to quality and our Credo have helped us achieve significant milestones as a company.
Biosense Webster is the world leader in the $2.5 billion worldwide electrophysiology market and our company is in the enviable position of being one of the fastest growing businesses within Johnson & Johnson. We have achieved double digit growth consistently over the last decade and aren't stopping as we look towards the future. Our product portfolio remains strong and further proves we are an innovative leader in cardiac electrophysiology. In order to continue this great growth trajectory, we need to bring on board top talent like you to help fuel our future! Our growth has also enabled a relentless focus on talent development by providing many new opportunities for our employees to expand their knowledge and grow their careers. Our commitment to developing our leaders is unwavering. Our investment in people, technology, and innovation make us one of the best places to work within one of the most admirable corporations in the world.
The Senior Quality Tech, 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 Senior Quality Tech 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.
A minimum of a High School degree is required; some college coursework would be preferred. A minimum of 8 years experience as a quality technician or QC inspector in a regulated environment 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 in the Microsoft Office suite of products, including MS Word, MS Excel, and MS Outlook is required. Strong written and verbal communication skills are required. This position is located in Irwindale, California.
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Primary Location: North America-United States-California-Irwindale
Organization: Biosense Webster Inc. (6010)
Johnson & Johnson Family of Companies - 2 years ago
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