Commercial Quality Compliance Specialist

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Quality

Customer/Commercial Quality

Professional

Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of America

DePuy Synthes is recruiting for a Commercial Quality Specialist located in Raynham, MA, with considerations given to support remotely from the US at the discretion of the business.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes, and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
DePuy Synthes provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to healthcare systems worldwide. For more information, visit

The DePuy Synthes Commercial Quality Specialist is responsible for the development, execution and oversight of Quality and Compliance (Q&C) programs for the DePuy Synthes Sales Inc. local operating company. This includes but is not limited to Distribution Centers, Loaner Distribution Points and Field Inventory Managers (internal and external) in the United States. This position resides in the DePuy Synthes Commercial Quality Organization.
This position may focus on “last mile” delivery of surgical loaner sets supporting orthopedic customers across the US. This position serves as a liaison with Franchise Quality, Sales, Commercial Operations and Supply Chain partners on commercial and distribution quality related matters to drive timely resolution of quality related issues. This position identifies and supports implementation of fit for purpose quality and compliance improvement opportunities consistent with DePuy Synthes business objectives, Quality Standards, and applicable regulations, while considering the customer experience.

Bachelor Degree in regulatory compliance or science or engineering with at least 2-years experience in regulated healthcare industry, OR Associates degree with minimum of 5 years of experience in a regulated healthcare industry.

• Knowledge of applicable FDA regulations and ISO-13485 standards.
• Self-directed with flexibility to work independently and on teams.
• Ability to collaborate and communicate concepts in a way that is easily understood.
• Proven time and project management skills.
• Strong problem solving, root cause analysis and analytical experience.
• Supplier quality management experience…