Supplier Quality Engineer

• Responsible for Supplier Qualification, Supplier Change Notification, Supplier Corrective Action, Supplier Nonconformity Reports and Part / Service Qualification of all Quality Impacting Suppliers.
• Supplier Qualification / Requalification shall be led and performed on time, including audits and Supplier Quality Agreements.
• Supplier Nonconformities to be completed on time with containment, investigation, and disposition responsibility.
• Supplier Corrective Actions must eliminate reoccurrence and be completed on time through investigation, action plan, implementation, and verification.
• Supplier Change Notification (SCN) to be executed with cross Functional teams including RA, Engineering, Sourcing, and SMEs.
• Supplier Production Process Approval (SPPA) to be driven on time with supplier and SME coordination.
• Driving continuous improvement initiatives within the supplier base.
• Monitoring Supplier Performance and reporting at Quarterly Supplier Review Boards.
• Supporting global procedures, work instructions, and forms.

• 2 to 5 years

• Basic understanding of ISO 13485 quality management system requirements.
• Exposure to CAPA/SCAR activities such as containment and basic root cause analysis.
• Support experience in Supplier Change Notifications (SCN).
• Strong communication and stakeholder collaboration.
• Basic understanding of ISO and FDA (21 CFR Part 820) expectations.
• Supplier Quality exposure including audit support and NCR coordination.

• Knowledge of SPPA/PPAP/FAI methodologies.
• Experience supporting supplier audits and SQAs.
• Hands on NCR investigation support.
• Medical device industry exposure.
• Training/exposure to ISO 13485 auditing.
• Experience assisting in MDSAP/Notified Body/FDA inspections.
• Involvement in continuous improvement projects.
• Proficiency in MS Office; German language helpful.

• 20% travel flexibility

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