STAFF QUALITY ENGINEER-NPD Job

Job description

STAFF QUALITY ENGINEER-NPD-3292151207DescriptionBiosense Webster, Inc (BWI), a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Quality Engineer, located in Irwindale, California.
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.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Staff Quality Engineer participates 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 and other worldwide regulatory agencies), and other applicable standards as pertains 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.
The Staff 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 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.
QualificationsA Bachelor’s degree and a minimum of 6+ 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 preferred. 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. Previous experience as an Operations Engineer, with process development and optimization 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 (V&V) 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.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NAPrimary Location:North America-United States-California-IrwindaleOrganization: Biosense Webster Inc. (6010)Job Function: Quality (Eng)Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. EEO is the Law EEO is the Law GINA Supplement