Senior Quality Engineer - Risk Management | Irvine, CA

The company partners with clinicians to develop innovative technologies that improve the quality of care for arrhythmia patients worldwide. For more information, visit The Senior Quality Engineer - plans, coordinates and executes quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product.

Involved in New Product Development (NPD) teams and other activities to develop products, design verification tests, process validations and quality processes to ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards. As needed, assists to develop

quality-engineered systems and products, and support qualification and validation activities. Will be considered a subject matter expert (SME) on Quality matters, relevant Quality tools and will work on complex problems and projects.

Will show leadership in driving program/projects and innovating compliant approaches and solutions to problems. Shares technical expertise with others and develop other engineers. A few of the responsibilities may involve collaborating with other members of the Design Team. Will contribute to activities including risk management document development, creation, and design of catheter test methods, authoring of test protocols, and testing of products during

their development cycle. If you are and individual who enjoys working with the other team members and changing the lives of our patients around the world come join our team at Biosense Webster!

Key Responsibilities: Under limited supervision and general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: This position will support day-to-day responsibilities of maintaining the Risk Management System in accordance with ISO14971 and all Corporate, MD and CSS Standards. The position will be responsible for the ongoing maintenance of the Risk Management files for all current marketed product in accordance with all applicable requirements.

Reviews and continuously leads efforts to improve the Risk Management System at BWI Maintains dashboards and other reports of performance metrics as required. Provides regular updates and status reports to management. Initiates Company issue escalation process as required. Working with other functional groups, including R&D and Operations in support of new product development, engineering projects, quality assurance activities, and lifecycle management. Applying Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.

Remains informed of new or revised regulations and/or guidelines and backsses impact on company Risk Management processes. Supports internal and external audits Develop and establish effective quality control and support associated risk management plans, AFMEA, DFMEA and PFMEA. Review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders. Ensure that development activities follow design control requirements (Design Trace Matrix), product is tested per applicable standards, GSPR are met per the MDR, and product is properly transferred to manufacturing per applicable specifications.

Technical problem solving, failure analysis, and root cause determination. Makes decisions independently on engineering problems and methods and represents the organization in conferences to resolve important questions and to plan and coordinate work. Recommend issue resolution to management for significant capability and compliance issues. Works closely with functional leadership in planning and completing project milestones.

Plans, develops, coordinates, and directs one or more large important engineering projects or a number of small projects with many complex features. Carries out complex or novel assignments requiring the development of new or improved techniques or procedures. backsses the feasibility and soundness of proposed engineering evaluation tests, products or equipment when necessary, data are insufficient or confirmation by testing is advisable. Responsible for communicating business related issues or opportunities to next management levels.

Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Performs other duties assigned as needed Required: Bachelor's degree, required; preferably in engineering and/or scientific field. A minimum of 4 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations Critical thinking and investigation skills Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy Ability to function in a team environment and deliver on team objectives Ability to effectively collaborate and communicate with internal and external partners at all levels of the organization including influencing and negotiating resulting in positive business and quality outcomes.

Preferred: Ability to use broad knowledge of regulatory, technical, and business requirements to conduct due diligence backssments Ability to apply project management skills to ensure fulfillment of new product development requirements Ability to develop and implement Quality standards.

Demonstrated auditing and problem-solving skills Six Sigma/ Design for Six Sigma experience, and/or knowledge of Process Excellence tools Lean manufacturing experience Knowledge of Quality and operations systems and processes, including GMP Familiar with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices. Ability to function in a team environment and deliver on team objectives is required.

Professional demeanor on the phone and in email is required. Strong attention to detail is required. Prior medical device complaint handling experience, or knowledge of medical device regulations is required. Project management and/or process mapping experience. Strong written and verbal communication skills are required. Developed presentation skills. Other: This position is located in Irvine, California and will require up to 20% travel domestic and international. The anticipated base pay range for this position is $76,000 to $121,000. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www. careers.