Quality Eng 2

Biosense Webster, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Engineer II in Irvine, California! 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 purpose of this position is to ensure that Company will develop its products in compliance with quality assurance system throughout the product lifecycle. The scope of QA activities; company adherence to QA standards and processes; internal and external audits; and coordination between CSS companies. DUTIES & RESPONSIBILITIES Under general supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position includes the following duties: Quality Product Development Responsible for Product Development processes in compliance with standards and regulations; implement methodologies and initiate improvements Lead and implement Quality processes and standards for new product introduction (including internal JnJ standards and processes Analyze and review approval processes. QA Compliance Function as the QA representative to comply with all JNJ NPD compliance standards Perform product and process internal audits and preparation for external audits as required Ensure that project team are aware of and comply with relevant standards and processes General Responsible for communicating business related issues or opportunities to next management level For those who supervise or manage a staff, responsible for ensuring that 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, if applicable Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Performs other duties assigned as needed Internal Interactions Part of BWIUS QA Org Interfaces with all CSS companies External Interactions Global program core team members and affiliates in the US and in Europe, J&J MD&D organization, BWI QA organization and RA organization. Qualifications EXPERIENCE AND EDUCATION Education/Training BSc in Engineering Advantage: Qualification in Quality Assurance (CQE, CSQE, CQM, CRE) Experience Experience as a Quality Engineer, preferred in medical device company with active class III devices REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS Required Knowledge (to be acquired by former experience or on-the-job training) Good knowledge of Six Sigma methodology EN ISO 13485 EN ISO 14971 QSR 21 CFR 801; 803; 806; 807; 820; 821; 830; 860 EU MDR 2017/745 & Directive EEC/93/42 MDSAP Required Skills or Abilities Good interpersonal relations Abilities to work with remote managerial position Good English skills (writespeak) Self-confidence and integrity Self-motivated and project-oriented, whether independently or with a team Motivator with good communication skills, both verbal and written Strategic thinking and Results and performance driven Big picture orientation with attention to detaill Company management reserves the right to add, delete or otherwise alter assigned duties at any time. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The minimum qualifications listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 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 Quality Requisition ID 2205998476W