Quality Systems Specialist
On-site · Seoul, Seoul, South Korea
Job Summary
Quality Systems Specialist will manage the QMS, GMP and PMV operations to ensure medical devices meet established quality standards in Korea. Responsibilities include maintaining QMS procedures and records, establishing training matrices, conducting internal audits and CAPA, supporting Post Market Surveillance audits, managing distributors/suppliers, change control and risk management, leading local/APAC improvement projects, handling Product Complaints and Adverse Event Reporting, overseeing Foreign Material reporting, and executing Field Corrective Actions. The role requires a Bachelor’s degree in medical/biological sciences or equivalent, 3-5 years of relevant quality experience (preferably in medical devices), strong English and Korean communication, KGMP audit exposure, and solid problem-solving and organizational skills. Proficiency in MS Office and a collaborative, results-driven mindset is essential.
Required Qualifications
- Bachelor’s degree in medical, biological science or equivalent
- 3-5 years of experience in a Quality Specialist role, preferably in medical devices
- Strong written and verbal communication in English and Korean
- Good understanding of Korea Good Manufacturing Practice (KGMP) and Medical devices class IV handling experience (highly regarded)
- Excellent problem-solving, attention to detail, prioritization and organizational skills
- Proficiency with MS Office and quality documentation systems
- Ability to operate autonomously and as part of a team
- Experience with QARA operations and regulatory alignment with global policies
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