Quality & Compliance Specialist
US Med Tech Commercial Quality is recruiting for a Quality & Compliance (Q&C) Specialist to support US Orthopedics Last Mile Commercial Operations, to be located in either California, Washington State, Oregon, Colorado, Arizona or Nevada. Remote work options may be considered on a case-by-case basis and if approved by the company.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential. At Johnson & Johnson, we all belong.
The US MT Commercial Quality Specialist is responsible for the development, execution and oversight of Q&C programs for the Med Tech local operating companies in the US. This includes but is not limited to Internal and External Orthopedic Loaner Distribution Points in the United States. This position will focus on compliance of “last mile” operations that handle and deliver surgical loaner sets to support joint reconstruction and other 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 Med Tech business objectives, Enterprise Quality Standards, and applicable regulations, while considering the customer experience.
Key Responsibilities:
- Establish relationships with DePuy Synthes Sales, Sales Agents, Commercial Operations, J&J DELIVER and Med Tech Franchise customers to solve problems and meet changing operations and regulatory environments.
- Define, implement, and validate quality system requirements and systems to meet departmental and business strategies.
- Mentor functional partners in the areas of GxP requirements.
- Implement and improve systems/processes with focus on; Customer and Commercial quality, Inspection readiness, Quality planning, Nonconformance and corrective action plan development, implementation and effectiveness monitoring.
- Provide quality support for existing and new distribution models & processes in the US.
- Guide the Operations on the development of standard operating procedures.
- Serve as single point of contact for assigned business partners.
- Participate in and lead audits, inspections, investigations, and remediation activities.
