Job Information
Stryker QA Manager in Seoul, South Korea
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine!
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
What you will do
Ensure company icompliant 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 in a professional manner
Maintain ISO 13485 certification of Stryker Korea
Be the key auditee facing the Corporate Quality Audit or any external audits to succeed in the audit
Lead Quality activities with other functional teams performed like Internal audits, supplier audits, CAPA, Customer surveys, Validation, Quality Management Review meetings, supplier management, etc., and ensure the latest version of quality documents is maintained and used at work as well as maintaining quality records properly.
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 regulations
Educate and collaborate with commercial, relevant functions and customers regarding QA matters
What you need
Bachelor’s degree in science, engineering, medical, law, etc.
Minimum 8 years of RAQA experience in the healthcare industry
Well-organized, logical thinking with strategic and good planning skills.
Professional communication skills in English
Passionate and a great sense of responsibility
Committed to punctuality, discipline & detailed
Team management experience
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.