Biosense Webster is recruiting for a Sr. 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 increasing the accuracy, speed, and efficiency of the cardiac ablation procedure.
The Sr. Engineer will be supporting project teams in the development of electrophysiology catheters and systems at Biosense Webster and provides advice and mentorship to less experienced personnel. The successful candidate will be working within a cross-functional project team through all phases of the product development process, planning and executing projects through the product launch. The candidate will work closely with members of the project core team (R&D, Product Management, Marketing, Finance, Sourcing, Plan, External Manufacturers etc.,) to define user needs, generate design concepts and prototypes, perform quality control evaluations and support development of product and process validation plans and testing. The candidate will also be involved in test method development and evaluation of the proposed design.
The Sr. Quality Engineer will prepare, conduct, monitor and report on audits of all quality system categories to assess compliance to good manufacturing practices, equipment engineering system, and international organization for standardization standards.
The Sr. Quality Engineer will be responsible for:
Providing complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes.
Utilizing 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).
Addressing and correcting product and process complaints.
Reporting on contract manufacturer performance metrics and ensures management reviews.
Overseeing audits of all quality system categories to assess compliance to process excellence standards.
Ensuring comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management
Ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
- Bachelor's degree in an engineering discipline, preferably Quality Engineering experience is required.
- Minimum 4 years of engineering experience with a BS, or 2 years with MS in engineering is required.
- Minimum 3 years’ experience in a Quality Engineering environment is required
- Experience working in highly regulated industry is required: working in medical device is preferred.
- Experience working with an integrated cross-functional new product development team is preferred.
A Green/Black Belt Certification is preferred
Experience managing outside vendors and suppliers is preferred
Experience solving technical manufacturing issues is preferred
- Proficient knowledge of Process Excellence / Six Sigma statistical analysis techniques and its application in Quality Control/Management processes is preferred.
- Strong technical communication and negotiation skills and demonstrated ability to work independently with external suppliers is required.
- Ability to travel up to 10% domestic and international is required
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.
Biosense Webster Inc. (6010)