Job Summary

The Sr. QA Specialist will serve as a leader and Quality Representative, responsible for setting the Quality Management System (QMS) comply with Corporate and Korea regulations.

As the interface with regulators, global headquarters, and overseas manufacturers, the Sr. QA Specialist will bring quality compliance depth, driving continuous improvement and ensuring ZEISS Korea’s reputation as a trusted partner in the healthcare industry. Along with the healthcare part, this Sr. QA Specialist will also monitor RA/QA topics for ZEISS-related industry areas.

Job Description (information about role & responsibility)

1. Execute KGMP certification/renewals, QMS documentation and Enhance QMS in compliance with ISO 13485 and Korea regulations (KGMP, importer’s obligations, etc.)

2. Manage the documents control for all procedures and quality records ensuring clarity, consistency, and business alignment (i.e. SOPs, Work Instructions, Product Specification, etc.)

3. Systematic handling of complaints, nonconformances, CAPA, and trend analysis, ensuring patient safety and regulatory/quality compliance.

4. Conduct product release process including incoming inspection, CoA review, and labeling accuracy.

5. Perform adverse event reporting, vigilance, and field corrective actions, serving as escalation point to safety committees and global stakeholders.

6. Be accountable for internal and external audits in ZEISS VISION Korea including the follow-up actions

7. Prepare data for management review

8. Manage compliance with MDGSP, warehouse management, and nonconforming product controls

9. Provision of quality training and capability development to instill a culture of quality across the organization.

10. Communicate with ZEISS VISION global HQ, overseas manufacturers, and regulatory authorities for problem solving and resolution

11. Execute general quality administration duties and compliance requirements as assigned

12. Ensure compliance with relevant regulations (i.e. Medical Devices Act, Digital Medical Products Act, Consumer Chemical Products and Biocides Safety Control Act, etc.)

13. Quickly report and escalate identified issues to the team if necessary

14. Collaborate with RA to support any regulatory issues if necessary

Qualification (education, job experience, knowledge, personal attribute)

• 10-15 years QA experience in Medical Device Industry, with a strong background in importer operations
• In-depth knowledge of MFDS regulations, ISO 13485, KGMP, and GMP audits
• Excellent communication skills in both Korean and English, with ability to liaise with global HQ and overseas manufacturers
• Good interpersonal skills

Preferred Qualifications

• Experience in multinational medical device companies
• Strategic mindset with strong problem-solving and risk management skills
• Advanced degree in Quality Affairs or related fields

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