Johnson & Johnson Careers
Director, Quality and Compliance - Acclarent
Requisition ID: 1102180831
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.
- 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.
- 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
Acclarent, Inc. (6206)