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Director, Quality & Compliance
Johnson & Johnson
Irvine, CA, United States
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Director, Quality and Compliance - Acclarent
Johnson & Johnson's Family of Companies is recruiting for a Director, Quality and Compliance to be located in Irvine, CA to support our Acclarent business.
Chronic sinusitis affects 3 million Americans each year and five per cent of the U.S. adult population suffers from a phenomenon referred to as Eustachian Tube Dysfunction (blocked ears / ear pain). Acclarent, Inc. is dedicated to supporting otolaryngologists with minimally-invasive ENT technologies that relieve this suffering as effectively and painlessly as possible. For more than a decade Acclarent, Inc. has pioneered innovative technologies, including the balloon dilation system that’s been used to treat more than one million patients.
The Director of Quality & Compliance is 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 Operations, Regulatory, R&D, Sales, Training and Marketing to assure all operations of the company comply with applicable QSR, ISO and FDA regulations. The Director of Quality & Compliance also serves as the Management Representative.
DUTIES & RESPONSIBILITIES
• Plans and directs resources 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.
• Creates 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.
• Chairs the Quality Review Board.
• Assures the implementation of policies and strategies for systems to assure compliance with regulations and industry standards.
• Determines organizational structure and allocation of responsibilities within the Quality group and works closely with cross-functional partners to determine resource allocation.
• Provides 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.
• Other responsibilities as required or assigned by manager.
QUALIFICATIONS
• Bachelor’s degree in Engineering, physical or biological sciences, or other related field is required
• Master’s degree in physical or biological sciences, or MBA is preferred
• CQM or CQE certification from the American Society for Quality (ASQ) is preferred
• At least 10 years of professional experience in a regulated healthcare industry is required
• At least 5 years of management experience is required
• Demonstrated knowledge of and compliance with applicable Quality System requirements is required. (For example: QSRs, ISO, GXP and MDD requirements)
• 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 preferred
• Strong written and verbal communication skills to communicate effectively at all levels is required
• Strong problem solving and time management skills are required
• Position is located at our J&J Office in Irvine, CA
• Up to 30% travel may be required