AMVETS Jobs

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.

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

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.