Senior Source Quality Engineer Strategic Initiatives

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Job Description

The Johnson & Johnson Medical Devices Companies is currently recruiting for a Senior Source Quality Engineer – Strategic Initiatives.  This role will be located in one of the following Medical Device (MD) locations: Somerville, NJ; Guaynabo, Puerto Rico; West Chester, PA; Cincinnati, OH; Raynham, MA; Warsaw, IN; or Monument, CO. 

The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.

We are MD Source Quality, as a team, responsible for ensuring a robust supply base for the Medical Device sector of Johnson & Johnson. The Senior Source Quality Engineer – Strategic Initiatives, will be responsible for the deployment of critical Source Quality strategies and associated standards, policies, procedures, programs and initiatives to accelerate the performance of the supply base. This position also may engage with the associated external suppliers of direct & indirect materials, finished goods and services, as needed.

You will use your talents to lead teams (Source Quality Engineers and others), collaborate with Strategic Sourcing/Procurement, R&D, Engineering/Technical Operations, Quality, Operations, business partners, and external suppliers to implement solutions and improve suppliers’ quality as well as their overall service and performance. In this role, you support the execution of plans/strategies, and implementation of systems, processes, and procedures to ensure robust supplier/purchasing controls with regards to the determination, selection, qualification, monitoring, and disengagement of suppliers. You will identify, develop, and own the investigation and resolution of supplier-related challenges, and implements appropriate Quality Engineering methodologies, statistical techniques, process capability analyses/improvements, process optimization, and other technical or Process Excellence tools in support of supplier-related process changes, risk management, product/process transfers, innovations, and continuous process improvements to improve supplier reliability, minimize risks, and ensure consistent sources of material supply capable of meeting or exceeding Quality, Compliance, and Business requirements.

Your Responsibilities:

  • Drive and manage Purchasing Controls related processes across the MD sector Source Quality function globally.
  • Lead, develop, and implement supplier/purchasing controls and associated activities including Approved Supplier List management, SQ Agreements, etc. across all MD sector Business Unit/Franchise Quality Systems
  • Develop and enable processes in support of the identification, selection, qualification, monitoring, and disengagement of suppliers.
  • Implement supplier change control process including change notification, dissemination of information, impact assessment, approval of changes, and supports material/supplier qualifications.
  • Lead component controls-related process improvements (qualifications, control plans, receiving inspection, etc) in collaboration with key business partners and the supplier’s applicable functional groups.
  • Own, drive, and lead the assigned Source Quality related projects, activities, initiatives with limited supervision.
  • Utilize Project Management methodologies to plan, organize, connect, craft, lead, and deliver results for assigned projects.
  • Prepare Supplier Quality Agreements and drive discussion with supplier while consulting with Source Quality Management.
  • Respond proactively to changing regulatory and business needs, including external standards.
  • Lead component controls-related process improvements (qualifications, control plans, receiving inspection, etc) in collaboration with key business partners and the supplier’s applicable functional groups.

This position may require up to 35% domestic and international travel.


A Bachelor's degree in Engineering or other equivalent technical discipline is required.

Professional experience in a regulated industry is required with medical device experience preferred.  

Five or more years related work experience in any quality function or equivalent technical field is required.

Project management experience is required.

Process Excellence/Lean/Six Sigma experience with certification is preferred.

QE certification (CQE) is preferred.  

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location
United States-Pennsylvania-West Chester-
Other Locations
North America-United States-Colorado-Monument, United States-Ohio-Cincinnati, North America-United States-New Jersey-Somerville, North America-United States-Indiana-Warsaw, North America-United States-Puerto Rico-Guaynabo, North America-United States-Massachusetts-Raynham
Medical Device Business Services, Inc (6029)
Job Function
Quality (Eng)
Requisition ID