Complaints Manager
DePuy Spine, Inc, a member of Johnson Johnson's Family of Companies, is recruiting for a Complaints Manager, located in Raynham, MA.
The DePuy Family of Companies has a rich heritage of pioneering a broad range of products and solutions across the continuum of orthopaedic and neurological care. These companies are unified under one vision - Never Stop Moving - to express their commitment to bring meaningful innovation, shared knowledge and quality care to patients throughout the world. DePuy Orthopaedics, Inc., DePuy Spine, Inc., DePuy Mitek, Inc., and Codman Shurtleff, Inc. develop and market products for reconstructing damaged or diseased joints; repairing and reconstructing traumatic skeletal injuries; facilitating the treatment of spinal disorders and deformity; repairing soft tissue in the shoulder, knee and other joints through minimally invasive means; and surgically treating neurological and central nervous system disorders. DePuy has three main locations: Warsaw, Indiana and Raynham, Massachusetts in the U.S. and Leeds in the UK.
The Complaints Manager shall provide leadership and direction to Complaint Investigation for domestic and international complaints assigned to DePuy Spine to drive consistency and ensure appropriate conduction of Complaint Investigation. This includes the analysis of incoming product complaints and determining requirements for investigation as well as the application of signal detection, tracking and trending to Complaint Investigation according to current procedures. This person will work with the appropriate functional departments to achieve effective complaint investigation. The position will also be responsible for monitoring effectiveness of corrective actions taken to prevent recurring complaints.
Additional responsibilities are to identify and report significant trends in complaints, potential product problems and potential recalls, and initiate immediate remedial action, if appropriate. This associate also may be responsible for organizing Health Hazard and Quality Review Board meetings when necessary He/She will work with appropriate functional departments including Quality Engineering, Development, Research, and Medical/Clinical to achieve effective complaint investigation. The Manager of Complaint Analysis will participate in internal audits and inspections conducted by global regulatory agencies as a subject matter expert. He/She will maintain and continuously improve procedures for highly effective complaints investigation processes and procedures. Additionally, the Manager of Complaint Analysis will participate in product risk assessments providing input in order to evaluate patient risk as required. He/She will provide input in requests from US and/or OUS regulators as required. He/She will provide input in response letters to complainants, surgeons and/or patients as required and lead team of complaints analysts.
Qualifications
A BA/BS in a scientific or technical discipline with 7 years of progressive compliance, clinical, quality, regulatory or related experience is required. Previous experience managing people or projects is required. Business experience in the medical device industry is required. Experience in Spinal Products is preferred. Experience with audits, complaints or investigations are preferred. Knowledge of FDA and clinical environments desirable. Must be self driven and able to work independently and prioritize multiple projects. This role is located in Raynham, MA and may require up to 10% domestic and international travel.
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