Associate QA Manager

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 required
• Proficiency 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