Essential duties & responsibilities: (detailed description)
Lead Quality activities with other functional teams performance like Internal audits, supplier audits, CAPA, Customer surveys, Validation, Quality Management Review meetings, supplier management, etc., and ensure quality documents up to date.
Make the company compliant with/ MFDS requirements and manage the QA team in terms of post-market surveillance including labeling, Importer’s duty by MDA, maintenance of QMS, ensuring the appropriate product release to customers, etc. by requirements
Maintain ISO 13485 certification of Stryker Korea
Supervise 3PL’s quality management system to meet internal/external requirements and expectations.
Accountable for KGMP renewal certification for Stryker overseas manufacturers closely working with RA
Lead and participate in key QA projects required by Stryker entity of Korea, East Asia, Corporate, Divisions
Actively influence authorities to advocate Stryker and industry to shape the regulatory policies and regulation
Educate and collaborate with commercial, relevant functions and customers regarding QA matters
Education & special trainings:
Bachelor’s degree in science, engineering, medical, law, etc.
English communication skill requiredProficiency in utilizing Microsoft Office products (PowerPoint, Outlook, Excel, Word, etc.)
Qualifications & experience:
Minimum 8 years of solid RAQA experience in the healthcare industry
Well-organized, logical thinking with strategic and good planning skills.
Passionate and a great sense of responsibility
Committed to punctuality, discipline & detailed
Team management experience
Travel Percentage: None