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Director of Quality and Compliance
Requisition ID: 9867180208
Johnson & Johnson’s Cardiovascular & Specialty Solutions (CSS) Group within Medical Devices is recruiting for a Director of Quality and Compliance for Mentor Worldwide located in Irvine, CA or Irving, TX. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology, Surgical and Non-Surgical Aesthetics, Sedation and Reprocessing.
Mentor Worldwide LLC is a leading supplier of medical products for the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow patients to improve their quality of life through breast, body and facial aesthetics. Learn more about Mentor at <ahref="www.mentorwwllc.com">www.mentorwwllc.com</a>
You, The Director of Quality & Compliance are directly responsible for establishing quality policies, strategies and objectives for the company in collaboration with the Senior Management Team. The Director of Quality & Compliance works cross-functionally with Supply Chain, Regulatory, R&D, Sales, Marketing, and other departments to assure all operations of the company comply with applicable QSR, ISO and FDA regulations. The Director of Quality & Compliance also serves as the designated Management Representative.
- Plan and direct resources directly and indirectly and activities of the quality functions. Manages subordinates in areas of quality and is responsible for the overall direction, coordination and evaluation of quality matters.
- Create long-range quality plans for the organization focusing on the effective development of new products and establishing systems to ensure Life Cycle Management of products.
- Lead effective establishment of organizations that support business process and compliance, quality risk management, design assurance, internal audits, corrective and preventive action, records management and document control, complaint management and medical device reporting and management of quality data across disciplines.
- Chair the Quality Review Board.
- Assure the implementation of policies and strategies for systems to assure compliance with regulations and industry standards.
- Determine organizational structure and allocation of responsibilities within the Quality group and works closely with cross-functional partners to determine resource allocation and fiscal budgets.
- Provide updates to company, franchise management and Johnson & Johnson corporate quality regarding compliance status and performance of the companies within the operating group relating to quality.
- Partner with business and functional leaders to drive risk mitigation, proactive action and continuous improvement. Communicates and promotes Quality vision and goals. Recruits and retain high caliber Quality professionals.
- Other responsibilities as required or assigned by manager.
- A Bachelor’s degree in Engineering, physical or biological sciences or related field is required.
- A minimum of 10 years of experience in a regulated industry associated with the life sciences is required.
- A minimum of 5 years of management experience is required.
- Demonstrated knowledge of and compliance with applicable Quality System requirements (e.g., QSRs, ISO and MDD requirements) is required.
- Experience working with regulatory authorities and certification bodies is required.
- Strong mathematical skills (i.e., frequency distributions, reliability and validity of tests, normal curve, analysis of variance, correlation techniques, sampling theory or factor analysis) is required.
- Strong written and verbal communication skills to communicate effectively at all levels are required.
- Strong problem solving skills, time management, and communication skills are required.
- A Master’s degree in in physical or biological sciences is preferred.
- CQM or CQE certification from the American Society for Quality (ASQ) is preferred.
- This position is located in Irvine, CA or Irving, TX and may require up to 30% travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
North America-United States-Texas-Irving
Mentor Worldwide LLC (6177)