Critical success factors / key deliverables:

• Make company be compliant w/ MFDS requirements in terms of post market surveillance including labeling, Importer’s duty by MDA, maintenance of QMS, ensuring the appropriate product release to customer, etc
• Do and manage QA team to perform post market surveillance activities like Product complaint handling, Product Field Action, Adverse Event reporting, etc in accordance with requirements in professional manner
• Responsible for maintaining ISO 13485 certification of Stryker Korea
• Be the key auditee facing at the quality audit from Corporate and/or external party to succeed audit
• Lead Quality activities with other functional teams performed like Internal audit, supplier audit, CAPA, Customer survey, Validation, Quality Management Review meeting, supplier management, etc and ensure the latest version of quality documents be maintained and used at work as well as maintaining quality records properly
• As the representative of QA, supervise 3PL’s quality management system to meet internal/external requirements and expectations incl. product labeling, storage & warehousing control, facility control, etc.
• Responsible for local labeling process to ensure regulatory compliance including e-IFU but not limited to
• Accountable for KGMP renewal certification for Stryker overseas manufacturers closely working with RA
• Efficiently manage and lead GX program(dealer management process) in terms of QA perspectives, UDI labeling with reporting, and OEM approval process
• Lead and participate in key QA projects required by Stryker entity of Korea, East Asia, Corporate, Divisions
• Actively influence authority to advocate Stryker and industry to shape the regulatory policy and regulations. Be a good example as a representative of company at industry meeting or MFDS meeting as professional manner
• Closely monitor regulation changes and responsible to update to East Asia, Corp & Divisions, if applicable
• Successful team management with high engagement of team members through by training, feedback, 1:1 etc.
• Educate, collaborate commercial, relevant function and customers for QA matters
• People Management : As a QA team manager, responsible for recruiting, training, development, supervising and managing team with high engagement level. Show mature leadership to the team and organization as a middle manager group and the inclusion RA and entire business groups as by team winning mindset

Job Requirement - Knowledge / Skills / Attributes

• BA in science, engineering, medical, law, etc.
• Min. 12 yrs of RAQA experiences in healthcare industry
• Fluent in English
• Well-organized, logical thinking with strategic and good planning skills. Professional communication skills
• Passionate and a great sense of responsibility
• Committed to punctuality, discipline & detailed
• Leadership/People management experience is prefered