BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
Lead and maintain Supplier Quality Management activities, including supplier qualification, audits, performance monitoring, and Approved Supplier List (ASL) management.
Manage customer complaints and adverse event reporting in compliance with MFDS and BD requirements.
Coordinate complaint investigations, trend analysis, and corrective actions with global and local stakeholders as a Quality Business Partner.
Prepare and manage KGMP certification activities, including new registrations, renewals, changes, document reviews, and on-site audits.
Support regulatory inspections, for-cause inspections, and communications with regulatory authorities.
Maintain and improve QMS processes, including document control, records management, and eIFU management.
Lead or support local, regional, and global quality improvement projects.
Ensure compliance with applicable quality standards, regulations, and BD Quality System requirements.
Bachelor’s degree in science, engineering, or a related field preferred but not limited.
Minimum 5 years of experience in Quality Assurance, Quality Systems, or related functions.
Experience in medical device or healthcare industries preferred.
In-depth Knowledge of KGMP regulation, Quality Management Systems (e.g. ISO13485) and relevant regulatory requirements.
Proven experience in conducting supplier audits, or ISO 13485 Internal and external audits.
IRCA QMS Auditor or ASQ certification (e.g. CQA, CQE) are a plus
Advanced English proficiency, including professional written and verbal communication with global stakeholders.
Strong understanding of CAPA processes, problem-solving and analytical skills
Strong communication, interpersonal, and presentation skills in both Korean and English
Ability to work independently, manage multiple priorities, and drive results in a fast-paced environment.
Proficiency in Microsoft Office applications.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit https://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
Required Skills
Optional Skills
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KOR South Korea - Seoul HQ
