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Supplier Quality Engineer

Thermo Fisher Scientific · Wrocław, Lower Silesia, PL

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards Job Description Responsibiliti...

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions: Adherence to all Good Manufacturing Practices (GMP) Safety Standards Responsibilities: Requirements: - Qualification, evaluation, and continuous monitoring of suppliers in accordance with ISO 9001 requirements, applying risk-based supplier classification and performance management principles; - Ensuring that supplier controls meet the expectations of customers operating under ISO 13485 and/or GMP environments; - Management of supplier-related nonconformities, including structured root cause analysis, corrective actions, and effectiveness verification; - Oversight of externally provided processes with focus on documentation control, traceability, validation support, and compliance-relevant records; - Evaluation and approval of supplier change notifications, including structured risk assessment and customer impact analysis; - Driving supplier quality performance improvement through KPI monitoring, escalation management, and development initiatives; - Planning and execution of supplier audits when required, including preparation for customer audits and support during external inspections. - Degree in Engineering, Quality Manag...