Johnson & Johnson Careers

Senior Director, Quality & Compliance, DePuy Synthes Joint Reconstruction

Warsaw, Indiana
Quality (Generalist)


Job Description

Requisition ID: 7966190220

JOB PURPOSE:  

  • The DePuy Synthes Joint Reconstruction Management Representative. Leading the development, implementation and continuous improvement of the DePuy Synthes Quality Management System for Joint Reconstruction
  • Lead the development and execution of quality deliverables, enabling effective and compliant New Product Development (NPD) activities
  • Lead with an end to end Enterprise & Franchise mindset to ensure a customer centric approach is maintained and promoted in all areas of the business

SCOPE/BUSINESS COMPLEXITY:

  • Quality Lead for the Joint Reconstruction Platform Leadership Team (PLT)
  • Quality Lead for stage gate meetings for Joint Reconstruction product development
  • Multi- facility leadership to include Warsaw, USA and Leeds, UK  
  • Leading Quality to support Joint Reconstruction compliant sales growth in line with the strategic business plan

 INTERACTS WITH:

  • DePuy Synthes Joint Reconstruction Leadership Teams to include the leaders of R&D, Operations, Quality, Regulatory Affairs, Marketing and Commercial
  • J&J Quality Professional Community
  • J&J Supply Chain
  • External Regulatory Authorities
  • External Manufacturers

 MAIN RESPONSIBILITIES:

  • Provides a comprehensive Quality Management Strategy for the DePuy Synthes Joint Reconstruction organization
  • Executes the Quality Vision/Goals & Objectives as aligned with DePuy Synthes Business Vision and Strategies
  • Ensures effective Technical Design Reviews and effective implementation and utilization of quality tools for NPD
  • Monitors quality metrics across the business unit to identify systemic product and process issues assuring appropriate investigation, correction, and corrective and preventive action is taken when needed 
  • Monitors worldwide regulatory and technical standards environment for changes in quality trends and requirements.  Assesses impact and makes recommendations and implements required quality system changes
  • Builds and develops an organization of leading Quality professionals to create effective quality processes at all levels
  • Partners with business functions to provide governance and technical support for Base Business Life Cycle Management projects associated with safety, compliance, business continuity and cost Improvement 
  • Develops and leads innovative initiatives in Quality to improve business performance and maximize customer value
  • Support the Quality activities for Acquisition and Divesture opportunities as requested by the PLT
  • Fosters an environment of innovation within the Quality function
  • Proactively evaluate, communicate, manage and mitigate risk
  • Develops and manages the Joint Reconstruction Franchise Quality Engineering business plan in line with long range financial planning objectives


Qualifications
  • Bachelor’s Degree in a technical discipline is required, master’s degree preferred
  • A minimum of 10 years of business experience is required, with at least 5 of those years in Quality, Regulatory or a related discipline within Medical Device
  • A minimum of 5 years people management experience is required 
  • NPD Quality Experience required specific to QSR/ISO 13485:2016 Design Control requirements 
  • Direct experience leading Notified Body/FDA audits is required
  • Strong knowledge of FDA and EU regulatory compliance for Medical Devices is required 
  • Ability to effectively present complex information in a clear and concise manner is required 
  • Strong skills with a proven track record in managing process validation and failure mode effects and analysis is required
  • Previous experience managing multiple projects is a required
  • Ability to effectively negotiate and influence upper management, other departments and regulatory agencies is required 
  • Ability to clearly communicate to a variety of audiences, both big picture ideas as well as technical details is required 
  • Experience of developing concise and audience-focused communications, both written and for presentations is required 
  • Excellent communication and interpersonal skills are required
 
 

THIS JOB DESCRIPTION IS NOT AN EXHAUSTIVE LIST OF THE JOB HOLDERS RESPONSIBILITIES



Primary Location
United States-Indiana-Warsaw-
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Quality (Generalist)
Requisition ID
7966190220