Senior Quality Engineer

Biosense Webster Inc. part of the Johnson & Johnson family of companies is currently recruiting for a Senior Quality Engineer located in Irvine, CA Atrial fibrillation (AFIB) is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications. 20 million people around the world suffer from AFIB each year. Biosense Webster, Inc. is the global leader in the science of diagnosing and treating heart rhythm disorders. The company established its leadership in electrophysiology with the development of the first real-time, 3D cardiac mapping and navigation technology, as well as the first electrophysiology catheter. The introduction of the company’s CARTO® 3 System in 2009 revolutionized 3D mapping technology by improving the accuracy, speed, and efficiency of the cardiac ablation procedure. The Senior QE will provide overall quality assurance leadership in the management of select New Product Development project or legacy product engaged in the development or sustenance of Johnson and Johnson medical device products. Conducts audits to good manufacturing practices, international organization for standardization and any other applicable standards. Duties include: Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes Utilizes multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO) Addresses and corrects product and process complaints Reports on contract manufacturer performance metrics and ensures management reviews Oversees audits of all quality system categories to assess compliance to process excellence standards. Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management. Handles complex technical issues for manufacturing processes that are to be transferred to satellite facilities Other related duties maybe assigned Qualifications Education: A minimum of a Bachelor’s degree required; preferably in Engineering or related technical field Required Skills & Experience: A minimum of 5 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry Knowledge of GD&T (Geometric Dimensioning and Tolerancing) Ability to develop and implement Quality standards Thorough knowledge of Quality and operations systems and processes, including GMP and QSR requirements for medical devices Thorough knowledge of leading-edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies Demonstrated problem solving skills Good understanding of theoretical and practical fundamentals and experimental engineering techniques Competent using MS Office (word, excel, power point, outlook, etc.) Ability to multi-task and manage multiple assignments in a timely manner Good verbal and written communication skills Strong interpersonal and leadership skills Strong analytical skills Ability to travel up to 10%, international and domestic Preferred Skills & Experience: Ability to apply project management skills to ensure fulfillment of new product development requirement Experience working in both an FDA and European regulatory environment A thorough understanding of GMP/ISO regulations and validation regulations American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools Six Sigma Green/Black Belt Certified Do you want to be part of a diverse team delivering innovative products to market? Apply today! At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Primary Location United States-California-Irvine-31 Technology Dr Organization Biosense Webster Inc. (6010) Job Function Engineering Requisition ID 2206058880W