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Stryker

Associate Qa Manager

Posted on Nov. 27, 2024

11, South Korea
No Salary information.

Full Time

Why join Stryker?

Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
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.

Job description

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.

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

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.

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