Senior Source Quality Engineer

The Ethicon Surgical Care business offers a broad range of products, platforms and technologies that are used in a wide variety of minimally invasive and open surgical procedures. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open surgery.

We are currently looking for a 

Senior Source Quality Engineer (m/f/d) 

in Norderstedt

• The Senior Source Quality Engineer (Sr. SQE) provides overall quality assurance leadership in the management of External Manufacturers engaged in the production of Johnson and Johnson products. The Sr. SQE will be responsible for external suppliers of finished goods and services for the Ethicon franchise. The candidate owns the deployment of the Source Quality Management (SQM) strategies and associated standards, policies, procedures, programs, systems, processes, and initiatives for suppliers of the Ethicon supply chain.
• The primary location of the position to be based at ETHICON manufacturing and/or ETHICON office sites.

Responsibilities Summary:

• Provide timely business support for the assigned Ethicon Source Quality Management (SQM) function globally.
• Lead, develop, and implement supplier/purchasing controls and associated activities including Approved Supplier List management.
• Participate in and/or support the identification, selection, qualification, monitoring, and disengagement of suppliers for Source Quality Management. May lead this process under the guidance of Source Quality Manager and/or management representative.
• Collaborate with suppliers and business partners to ensure robust materials, products, processes, and systems.
• Partner with Procurement, R&D, Engineering/Technical Operations, Quality, Operations, and Suppliers in the timely investigation, resolution/prevention of supplier-related issues to minimize/prevent business disruptions.
• Supervise and analyze supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes.
• Implement supplier change management process including change notification, dissemination of information, impact assessment, approval of changes, and supports material/supplier qualifications.
• Own, drive, and lead the assigned Source Quality related projects, activities, initiatives with limited supervision.
• Develop/execute Quality Risk Management process for supplier-related matters with partnerships of subject-matter experts
• Own and lead the Source Quality Relationship Management (SQRM) process for the assigned suppliers (e.g. Lead periodic SQRM meetings including supplier quality performance reviews, supplier investigation follow-ups, investigation responsiveness/cycle time, targeted improvement plans (TIP), closed loop corrective actions, NC reductions, supplier quality metrics, etc.).
• Take actions to identify internal customer requirements and translate customer requirements into potential proactive improvements to components or supplier quality systems. Proactively pursue clarification to confirm understanding of internal customer needs and requirements. Follow up on commitments and keeps customer, management and appropriate parties apprised.
• Respond proactively to changing regulatory and business needs.
• Lead component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups.
• Apply appropriate Quality Engineering and PEx tools to support innovations and continuous improvements
• Responsible for communicating business related issues or opportunities to next management level.