Job Description

1. Provide expert consulting on designing, optimizing, and implementing global and U.S., specific quality management systems, ensuring alignment with alignment with industry best practices and regulations.





2. Support GCP - compliant software development/maintenance quality assurance, with a focus on meeting U.S. standards (e.g., FDA, ICH GCP).





3. Advise on internal audit planning, execution, and follow-up to align with U.S. regulatory expectations and identify process improvements.





4. Support U.S. market system certifications (e.g., ISO 13485, FDA21 CFR Part 11), including audit preparation and compliance.





5. Collaborate with cross-functional teams (R&D, Engineering, Product) to provide quality guidance, resolve compliance issues, and boost quality awareness.





Monitor U.S. regulatory updates (e.g., FDA guidelines, GCP changes) and deliver timely insights to stakeholders for ongoing compliance.