Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities. If you are interested in working at one of the World's Best Workplaces, apply now!
Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team
This role leads QMS and QA of Stryker Korea to meet the requirement of regulatory health authority and expectation of Stryker Corporate policy. This role contributes to enhance Stryker Korea's QMS and grow Stryker Korea's business resulting by accurate, professional & in-compliance services.
- Do and manage QA team to perform post market surveillance activity like Product complaint handling, Product Field Action, Adverse Event reporting, etc in accordance to requirements in professional manner
- The role makes the company be compliant to MFDS requirements in terms of Importer's duty with cooperation with Stryker Divisions to keep quality inspection records from Division and to allow product release finally
- Regarding 3PL warehouse, this role to supervise 3PL's quality management can meet Stryker's expectations including product labeling, storage & warehousing control, facility control to protect product quality, etc.
- As the process owner of the Quality Documents and Quality Records, ensure the latest version of quality documents in Stryker Korea should be maintained and used at work as well as quality records management.
- Responsible for that ISO certification and related activities performed as professional and efficient manner like in Internal audit, CAPA, Customer survey, Validation, etc. & supports Quality Management Review meeting
- Be key auditee from internal and external audit regarding Stryker Korea's QMS supporting QMR for success
- UDI monthly reporting as compliant to the requirement, in collaboration with RA, IS, Dealers & MFDS
- Manage GX program, dealer management process in terms of QA perspectives
- Participate in key QA projects required by Stryker Corporate, divisions and regulatory authority
- Closely monitor regulation changes and influence authority to advocate Stryker for the favorable outcome
- Responsible to update Korea's regulatory requirements to Corporate RAQA & Divisions if applicable
- Successful team management with high engagement of team members through by training, feedback, 1:1 etc.
- Collaborate with biz franchise, relevant functional teams and customers to enhance Stryker Korea's QMS
- Be a good example of representative of company at external industry meeting or to MFDS as the professional manner of an opinion leader
Key strengths / personal attributes for the role:
- Degree in science, engineering, medical, or related
- At least 6~7 years of RA/QA experience in healthcare industry
- Relevant experience facing to government officials
- Fluent in English to work with region
- Well-organized, logical thinking. Strategic and planning skills
- Passionate and a great sense of responsibility
- Committed to punctuality and discipline
- Strong communications & negotiations skills
- People management and leadership skills
Allocate the work, provide leadership, guidance for the team. As a people manager, provide coaching, constructive feedback and development opportunities aligned with Performance Management process.
Know someone at Stryker? Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/
About Stryker Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.
We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com