Senior Quality Engineer Risk Management - Irvine

Company: johnson&johnson
Location: Irvine
Posted on: August 5, 2022

Job Description:

b'This position will have responsibilities in the implementation and coordination of Risk documents across BWI. Biosense Webster, Inc., part of Johnson & Johnson Medical Devices Companies, is a global leader in the science of diagnosing and treating heart rhythm disorders. The company partners with clinicians to develop innovative technologies that improve the quality of care for arrhythmia patients worldwide. For more information, visit This position may have responsibilities across ETHICON and Cardiovascular and Specialty Solution (CSS) Companies Johnson and Johnson Family of Companies) including a span of multiple product platforms such as General Surgical Devices, Sutures, ENT, Infection Prevention, Electrophysiology and Surgical and Non-Surgical Aesthetics. RESPONSIBILITIES Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines: /xe2/x80/xa2 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. /xe2/x80/xa2 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. /xe2/x80/xa2 Reviews and continuously leads efforts to improve the Risk Management System at BWI /xe2/x80/xa2 Maintains dashboards and other reports of performance metrics as required. /xe2/x80/xa2 Provides regular updates and status reports to management. Initiates Company issue escalation process as required. /xe2/x80/xa2 Remains informed of new or revised regulations and/or guidelines and assesses impact on company Risk Management processes. /xe2/x80/xa2 Supports internal and external audits (e.g. FDA) of risk management activities. Essential functions are the key tasks and responsibilities of the specific job, for example: /xe2/x80/xa2 Support ongoing maintenance of the Risk Management files for all current marketed product in accordance with all applicable requirements. /xe2/x80/xa2 The role requires interaction with the Complaints Management Department (CMD) and Post Marketing Surveillance Group (PMS) to provide updates to the applicable risk documents. Additionally, the position will work to improve the systems utilized within the New Product Development groups ensuring compliance to existing procedures and uniformity of risk assessments performed on new products. /xe2/x80/xa2 Collaborates with the, Medical Safety, Medical Affairs, Manufacturing, New Product Development (NPD)/Life Cycle Management (LCM) Teams and other departments to ensure compliance with applicable risk standards. May participate in the generation of risk documents as part of the applicable design phase within the Product Development Process. /xe2/x80/xa2 Responsible for communicating business related issues or opportunities to next management level /xe2/x80/xa2 Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures /xe2/x80/xa2 Performs other duties assigned as needed Qualifications /xe2/x80/xa2 A Bachelor/xe2/x80/x99s degree in Science, Engineering, Biology, Chemistry or related technical field is required. /xe2/x80/xa2 4+ years of related experience, including significant experience working in pharmaceutical, consumer, medical device or another highly regulated industry. /xe2/x80/xa2 At least 2 years/xe2/x80/x99 experience in the Electrophysiology field is required. /xe2/x80/xa2 The following skills, abilities and certifications are either required or preferred as noted: Critical thinking and investigation skills are required. Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required. /xe2/x80/xa2 Candidates should be familiar with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices. /xe2/x80/xa2 Ability to function in a team environment and deliver on team objectives is required. /xe2/x80/xa2 Professional demeanor on the phone and in email is required. /xe2/x80/xa2 Strong attention to detail is required. /xe2/x80/xa2 Require prior medical device complaint handling experience, or knowledge of medical device regulations is required. /xe2/x80/xa2 Project management and/or process mapping experience. /xe2/x80/xa2 Strong written and verbal communication skills are required. /xe2/x80/xa2 Developed presentation skills 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 2105978461W'

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