DePuy Synthes, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director of Quality Operations to be located in Raynham, MA.
DePuy Synthes is a Johnson & Johnson company that is one of the leaders in the medical device industry. Our implants and instruments are used by orthopaedic surgeons to treat patients with conditions resulting from traumatic injuries, degenerative diseases, deformities, and sports related injuries. Our environment is entrepreneurial, learning-driven, and is as challenging as it is rewarding.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
The Director Quality Operations develops, implements, and maintains the Quality Assurance System and provides technical contributions in a team environment. Builds cross-functional and cross-departmental support, fostering overall group effectiveness. Manages the direction and development of quality assurance associates and inspection areas.
• The Director Quality Operations will perform all job duties in full accordance with the Worldwide Policies on Information Asset Protection, maintain password(s) as Confidential, and protect Critical Business Information.
• Recommends and guides implementation of functional strategies. Incumbent knows, understands, incorporates and complies with all applicable laws and regulations relating to DePuy's business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
• Manage the activities of metrology, calibration, FAS, floor and final inspection to ensure quality of products manufactured by DePuy with emphasis on continuous improvement.
• Assist in devising and implementing methods and procedures for inspecting, testing and evaluating production.
• Provides technical Quality support to assigned inspection and manufacturing area(s). Requires consistent application of standard and advanced principles, theories, concepts and techniques - examples include process excellence/six-sigma tools, formal DOE methods, etc.
• Develops, implements and conducts/coordinates training in Quality Systems procedures to enhance efficiency, compliance in the areas of Product/Component Disposition, Non Conformance System, Corrective & Preventive Action System(CAPA), and Device History Records/Retention.
• Fosters harmony within functional and other areas. Contributes to the functional milestones associated with specific projects and to cross-functional teams.
• Provides coaching, useful feedback and direction to direct reports and teams. Holds people accountable for measurable results. Mentors and facilitates successful team behavior within and across functional areas and promotes the business value of diverse perspectives.
• Performs audits as required. Gathers and analyzes data and identifies trends to improve quality assurance systems' overall compliance, effectiveness, and efficiency. Participates in Management Review, CAPA and MAP meetings.
• Investigates internal and external system failures and ensures successful resolution. Maintains quality assurance systems' inspection readiness. Compiles budgets, short and long range planning. Provides detailed justification for capital requests. Maintains compliance with company policies in regards to all safety, QSR and environmental issues.Qualifications
• A minimum of a Bachelor's degree is required, preferably in an Engineering, Life Science, or related discipline. A Master’s degree would be an advantage.
• A minimum of 10 years of quality and/or manufacturing experience in medical device field is required. A minimum of 3 years of people management experience is required.
• ASQ certification in quality engineering is preferred.
• In-depth knowledge and hands on experience with all elements of ISO/QSR requirements applicable to medical device design and manufacturing is required; Experience with FDA/notified bodies is also required
• Excellent organizational and team building skills; Knowledge and experience with computer software including Word, Excel, Power Point and Access.
• The ability to influence at senior levels and across functions building strong networks internally and externally is required. Experience delivering results through influence in a highly matrix environment are also required. Strong experience and proven record motivating leading and developing staff, in a highly changing environment is required. Must be a proven change agent.
• This position is located in Raynham, MA and will require up to 15% domestic travel.
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J2W: LI NAPrimary Location
Depuy Orthopaedics. Inc. (6029)Job Function