The position ensures consistent oversight and execution of QMS continuous improvement agenda across Korean business centre, supporting compliance with local regulatory requirements and Olympus global quality standards.
The position is an organizational expert for QMS monitoring and measuring method such as internal and external QMS audit, etc., and QMS improvement tool such as CAPA, etc., and an initiator for enterprise quality culture’s continuous improvement.
As local CAPA lead, the position provides expertise in the full CAPA/NC lifecycle, including not only each CAPA steps but also proper statistical method utilization, NC risk assessment, health hazard assessment determination, etc. Also, the position is a local representative in monthly CAPA NC Review Board (CNRB) meeting, and Design Assurance Technical Review (DATR) meeting among regional and global CAPA stakeholders.
As local audit lead, the position provides expertise to organize and conduct KGMP audit for Olympus foreign manufacturing sites and MFDS surveillance for Olympus Korea office, facility and warehouse. In addition, the position ensures plan and execution of internal audit for entire organization of Olympus Korea in compliance with Olympus global standard and MFDS regulatory requirement.
This position is also responsible for quality culture, and mindset change in alignment with region/global initiatives.

•    Support and promote Olympus’s Vision, Mission and Core Value
•    Develop QMS maturity model and metric which contributes to quality culture and mindset change and provide appropriate training for the employees in various functions
•    Represent Olympus Korea in global meeting of responsibility
•    Organize monthly CNRB meeting as local CAPA lead 
•    Attend weekly DATR meeting and support CAPA owners, coordinators and local CAPA process owner 
•    Upskill, mentor and coach CAPA/NC owners and teams
•    Review and approve local CAPAs to accelerate CAPA process
•    Provide proper NC/CAPA training to required Olympus Korea employees
•    Organize KGMP audit with Olympus foreign manufacturer and local stakeholders
•    Develop and conduct internal audit protocol per Olympus global standard
•    Ensure successful and timely closure of CAPA for audit findings
•    Monitor all corrective action and preventive action effectively maintained in the organization after successful CAPA closure
•    Monitor NC/CAPA/Audit KPIs and initiate/conduct recovery plan for KPI deviations
•    Attend quarterly Management Review meeting to present continuous improvement progress
•    Maintain confidentiality, safe work environment, and healthy working culture
•    Other duties may be assigned

•    8-12 years of QA in healthcare industry
•    5+ years of strong leadership of quality system or team
•    3+ years of practical experience with statistical tools

•    Exceptional attention to detail with strong observation skills
•    Excellent written and verbal communication capabilities
•    Strong organizational, time managing, and multi-tasking skills
•    Process-oriented mindset with focus on accuracy and repeatability
•    Ability to work collaboratively across functions
•    Ability to work effectively in remote based team
•    Proficiency in Microsoft Office Suite and Adobe Acrobat and/or related software
•    Thorough working knowledge of ISO13485:2016, KGMP, QMSR or equivalent
•    Multiple and key role experience for auditor and auditee
•    Excellent statistical method utilization capability in QMS activities such as CAPA, etc.
•    Strong analytical and problem-solving skills with ability to identify and resolve complex issues
•    Demonstrated ability to contribute to or lead process improvement or change initiatives
•    Native English and Korean
•    Other Considerations (travel/hours availability, etc.): Up to 20% domestic and international travel will be required