Assess, qualify, and provide support to procurement activities related to onboarding new suppliers, particularly in the area of medical devices and pharmaceutical packaging components (e.g., plastics, films, foils, labels, cartons, and sterile packaging systems).
Execute supplier audits (both on-site and remote) to verify alignment with ISO 13485, ISO 9001, GMP standards, and relevant regulatory frameworks.
Work closely with the Purchasing team to maintain and update the Approved Vendor List (AVL), ensuring that all supplier-related documentation (e.g., quality agreements, certifications, validation files) remains current and compliant.
Contribute to supplier onboarding processes, including risk assessments using tools such as FMEA and risk-based qualification approaches.
Ensure that supplier materials and processes meet all applicable regulatory requirements, including FDA (21 CFR Part 820/211), EU MDR, ISO 11607, and other r...