DePuySynthes is a member of Johnson & Johnson’s Family of Companies, is recruiting for Director Customer Quality - Health Authority Reporting.
DePuySynthes develops and markets products within five divisions: Joint Reconstruction, Spine, Power Tools, Sports Medicine and Trauma. Among these are products for reconstructing damaged or diseased joints; repairing and reconstructing traumatic skeletal injuries; facilitating the treatment of spinal disorders and deformity; surgical treatment of neurological and central nervous system disorders, and sports medicine devices for the treatment of soft tissue injuries. DePuySynthes is one of the largest businesses within Johnson & Johnson. The Director Customer Quality - Health Authority Reporting will develop strategy and optimize organizational design around FDA MDR and EU vigilance reporting for DePuySynthes. This role is also expected to provide expertise, direction and guidance to all of the DePuy-Synthes business units. The Customer Quality function at DePuy Synthes is responsible for the intake, investigation and health authority reporting of all customer complaints related to our products. You will be responsible for the health authority reporting for each of the five Depuy Synthes divisions and will build positive relationships with Product Development, Medical Safety, Regulatory Compliance, Operations, Business Quality, Commercial Sales and our Service and Repair teams. These groups are critical to the success of customer quality as they ensure ontime reporting, provide investigation support and inform reportability decisions for the Health Authority reporting team. This position will also be responsible for development of the team and fostering a strong quality culture. Expert communication and presentation skills are key to the role. Critical data will be reported to key leadership stakeholders as often as monthly with requests to mobilize the team for ad hoc analysis on a frequent basis.
• A minimum of a Bachelor’s degree is required, preferably in an Engineering, Life Science, or related discipline. • A minimum of Bachelor’s degree with 5+ years of experience or a Masters/Advanced degree and 3+ year of experience in a highly-regulated industry is required. • A minimum of 5 years of direct line management of people is required. • Medical Device industry experience is preferred. • Experience in the Pharmaceutical industry is an asset. • FDA and ISO regulations knowledge is required, with FDA CFR Part 820 and ISO 13485 knowledge preferred. • Auditing background is an asset. • Strong communication, teamwork, and analytical skills. • Strong in root cause analysis skills. • Experience or knowledge with machining manufacturing processes and injection molding an asset. • Six Sigma, Lean, or ASQ Certification and trainings an asset. • This position will require up to 40% travel. Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today. 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.
Primary LocationNorth America-United States-Pennsylvania-West ChesterOther LocationsNorth America-United States-Indiana-Warsaw, North America-United States-Florida-Palm Beach Gardens, North America-United States-Massachusetts-RaynhamOrganizationDepuy Orthopaedics. Inc. (6029)Job FunctionQuality Assurance
Internal ID: 2580170719