DePuySynthes is a member of Johnson & Johnson's Family of Companies, is recruiting for Director Customer Quality for our Power Tools division, which will be located in West Chester, PA.
DePuySynthes develops and markets products within eight divisions: Biomaterials, Craniomaxillofacial, Joint Reconstruction, Neurologics, 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 will develop vigilance reporting strategy for DePuySynthes and also manage the operation of the Custom Quality (complaint handling) teams in Palm Beach Gardens FL, Oberdorf Switzerland and third party contract forces. This role is also expected to provide expertise, direction and guidance to the DePuy-Synthes business unit. 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. The Director Customer Quality will build strong relationships with Product Development, Operations and our Service and Repair teams. These groups are critical to the success of customer quality as they provide investigation support and intake information to the customer quality group. This position will also be responsible for development of the team and fostering a strong quality culture.
Expert communication and presentation skills are critical 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 Bachelor's degree preferably in an Engineering, Life Science, or related discipline 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.
•Experience in the Medical Device industry 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 problem solving 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 be located in West Chester, PA and require up to 40% travel, including some international.