Location: Irvine, CA
Company: Johnson And Johnson
for the best outcomes. Quality products and approaches are achievable only through collaboration with the smartest minds in electrophysiology. For more than 30 years, we've been the global market leader in the science and technology of cardiac arrhythmia treatment, working with thousands of electrophysiologists to identify and develop diagnostic and treatment tools.
And through onsite training, online courses and our global education centers, we work together to set new standards every day. Learn more about Biosense Webster at and follow us on Linked In. This role will be responsible for supporting the external inspection and internal audits of the Source Compliance program. Serves on
cross site and segment project teams consistent with company goals and objectives to improve overall compliance performance to established metrics and requirements.
Key elements of the role involve supporting the management, tracking to closure of External Manufacturers and Suppliers commitments to mitigation of identified risks. Supports in the completion of Follow Up reports related to the tracking and completion of External Manufacturing commitments taken to mitigate identified risks Key Responsibilities: Supports development and implementation of source compliance follow-up program. Owns relationship with external partners to ensure timely mitigation of risks identified through
audit program. Requests and reviews documentation related to follow-up activities.
Assists in the development, review and implementation of policies. Assures that quality records are updated in a timely manner and are in compliance with and company procedures. Assures compliance with regulatory requirements and internal Johnson and Johnson and Medical Device procedures by supporting quality inspections, report audits, internal and external facility evaluations, system audits, and data reviews that support company development projects. Provides support for special projects. Ensures and maintains a state of inspection readiness for systems, processes, and procedures within area of responsibility.
Education: A minimum of a Bachelor's Degree in a technical or Science-related field Experience and Skills: Required: A minimum of 6 years in a highly regulated industry and at least 5 plus years of auditing experience in a highly regulated environment. Working Knowledge of 21 CFR Part 820, QSR, ISO 13485, SOR 98-282 CMDR (Canada Medical Device Regulations), J-PAL (Japanese), MDD (European) requirements, and knowledge of Brazil GMP and other applicable regulations and standards. Experience in Medical Device Industry. Medical Device experience is helpful however candidates with backgrounds in related industries are encouraged to apply Proven experience and understanding of the regulations surrounding MD and EUMDR This role needs the successful person to contribute to our external manufacturers so a confident communicator at all levels is required Preferred: Experience, supporting and leading Health Authority & Notified Body Inspections, handling internal audit program, expertise in ISO 13485, EUMDR, FDA CFR 820 is a must.
Preferred certifications on the following: Certified Lead Auditor, CMMI Lead backssor, Green Belt certified/Process excellence and project management.
Verbal and written communication skills, project management, problem solving, business/financial savvy, presentation skills, training/education methodologies, people leadership, talent development, etc. Other: Responsible for presenting 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 The salary for this position is anticipated to be between $90,000 and $115,000 This position is anticipated to have up to 25% travel 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..
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