Senior Specialist Supplier Quality
Core
Managing supplier quality activities, resources, and audits for the EMEA and US regions to ensure compliance with quality standards and regulations.
Role type
Senior Specialist Supplier Quality
Builds
Supplier qualification programs, audit schedules, and quality agreements for medical device and drug suppliers.
Domain
Medical devices and pharmaceuticals manufacturing
Deliverable
client delivery
Required skills
Supplier qualification and risk analysis, audit planning and execution, quality agreement negotiation, master data management, GMP compliance, ISO 9001/13485 standards knowledge, corrective action tracking, SAP proficiency, Trackwise system usage, data analysis and reporting.
Preferred skills
Medical sector supplier experience, knowledge of dialysis machines/components, manufacturing process expertise (injection molding, electronics, chemicals), QMSR/21CFR820 understanding, regional medical regulations knowledge, English and German language proficiency.
Responsibilities
Qualifying and approving new suppliers, conducting risk analyses and initial assessments, planning and executing supplier audits, maintaining supplier and quality data in Trackwise and SAP, drafting and monitoring quality agreements, following up on audit non-conformities and verifying corrective actions.
Seniority
Senior, hands-on IC
