About the Role
The Senior Quality Specialist serves as a Quality Business Partner responsible for ensuring compliance with applicable quality and regulatory requirements while supporting business continuity and operational excellence. This role leads to critical quality processes including Supplier Quality Management, Complaint Management, KGMP Certification, Quality System Document Control, and Regulatory Compliance activities within BD Korea.

Job Responsibilities

• 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.

Job Qualifications

• 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.