HireDiversity

Warsaw, IN, US

Quality Product Safety Lead-8714121105

Description

DePuy, Inc. a member of the Johnson & Johnson Family of companies is recruiting a Quality Product Safety Leader to be located in Warsaw, IN or alternatively in Cork, Ireland.

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.

DePuy Orthopaedics is the Joint Reconstruction business offering orthopedic devices, solutions and supplies for hip, knee and extremity reconstruction, in addition to cement and operating room products.

The Quality Product Safety Leader is responsible for activities related to product safety and risk management. The successful candidate will lead projects to investigate potential product performance and safety issues and ensure their appropriate documentation and escalation through established applicable quality systems. This role will review or provide input into complaint investigations, MDR/vigilance reporting decisions and risk assessments. He/she will review, coordinate or prepare reports for product performance related internal purposes and external queries and interact with regulatory bodies and external parties as required. This individual will partner with internal departments including R&D, Regulatory Affairs, Clinical Affairs and Medical Safety to drive consistency and continuous improvement of product safety related processes and procedures.

The Quality Product Safety Lead will: Leads cross functional projects related to investigations and reviews of product performance and safety data, e.g. post market surveillance, complaints, customer/market feedback. Ensures accurate documentation in the company's quality system by using applicable processes and procedures to ensure compliance.Identifies potential safety issues and ensures appropriate escalation. Reviews, coordinates or prepares reports for product performance related internal purposes and external queries e.g. from health ministries, competent authorities, and external joint registries. Interacts with regulatory bodies and external organizations as required. Reviews/Provides input into complaint investigations. Reviews/Provides input into MDR/vigilance reporting decisions as required. Reviews/Provides input in response letters to complainants, such as surgeons and/or patients as required. Interacts with surgeons/patients as required. Performs market/customer visits as required. Drives consistency and continuous improvement of product safety and risk management related processes and procedures. Collaborates closely with appropriate functional departments including Quality, R&D, Regulatory Affairs, Clinical Affairs and Medical Safety to achieve potential risks are appropriately addressed in a timely manner. Initiates/Facilitates/Provides input to meetings to discuss problems identified through product performance information. Provides input into product risk assessments as required. Participates in internal audits and inspections. Leads/Supports Franchise wide product safety and risk management related projects.

Qualifications


An MD (or equivalent medical degree), alternatively PhD in life sciences or equivalent discipline. Minimum 3 years experience in Quality, Compliance, R&D, Medical or Product Safety related field is required. Business experience in the medical device or pharmaceutical industry is required. Audit experience, experience with regulators such as FDA and/or Vigilance Reporting is preferred. Project management experience is required. Compliance background is preferred. A broad knowledge of DePuy products or orthopedic products and clinical applications of such products is preferred. The successful candidate must have strong collaboration and influencing skills and excellent oral and written communication and presentation skills, and he ability to multi-task, and strong organizational skills. Strong Analytic & Risk Management abilities are required. He/She must be self driven and able to work independently and prioritize multiple projects. Knowledge and experience of common biostatistical methods are required. Proficiency in the Microsoft Office suite of products is required. This position is located in Warsaw, IN or alternatively in Cork, Ireland and requires up to 20% travel.

Primary Location:North America-United States-Indiana-Warsaw
Organization: Depuy Products Inc. (6030)
Relocation: Eligible
Yes - Within Country
Travel:Yes, 25% of the time