Johnson & Johnson Careers
Manager, Customer Quality
Requisition ID: 3476181002
DePuy Synthes develops and markets products within eight divisions: Biomaterials, Craniomaxillofacial, Joint Reconstruction, Neurologic, 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. DePuy Synthes is one of the largest businesses within Johnson & Johnson.
DePuy Synthes is a member of Johnson & Johnson's Family of Companies, is recruiting for Manager Customer Quality for our Mitek division in Raynham Massachusetts.
The Manager Customer Quality will manage the operation of the Custom Quality teams in Raynham MA 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 Manager Customer Quality will be accountable to the business for the end to end process and will report out on the health of the process at various management reviews.
The team in Raynham is accountable for the intake and investigation portions of this process. This manager will be required to 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 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 in the Medical Device industry is preferred.
- Experience in the Pharmaceutical industry is an asset.
- FDA and ISO regulations knowledge are required, with FDA CFR Part 820 and ISO 13485 knowledge preferred.
- Auditing background is an asset.
- Strong communication, teamwork, and problem-solving skills is a requirement
- 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 20% travel.
Depuy Orthopaedics. Inc. (6029)