Medical Devices QA Manager (Wonju)

About Company:

About our Client

A well-known medical device manufacturing company

Role Summary

We are seeking an experienced QA professional specializing in Class IV medical devices for our client, well known for their products in aesthetic and skin health solutions. The role focuses on quality management, regulatory compliance, and adherence to international standards.

Key Competencies:

Key Responsibilities

• Prepare, operate, and maintain Quality Management Systems (ISO 13485, KGMP, MDSAP) for domestic and international

regulatory audits.

• Review validation documents and support qualification assessments for processes, equipment, and cleanliness.

• Issue manufacturing records and create/revise SOPs.

• Review shipping and distribution documentation.

• Handle customer complaints, conduct investigations, and prepare reports.

• Manage Corrective and Preventive Actions (CAPA) and related documentation.

• Develop internal audit plans and manage corrective actions.

• Draft, revise, and maintain quality manuals and procedures.

An Ideal Candidate:

Qualifications & Experience:

• Experience: minimum 7 years of experience in Regulatory Affairs within the Class IV medical device industry.

• Education: Bachelor’s degree or higher in related discipline.

• Language: English proficiency (written and verbal).

• Proven expertise in international standards and regulatory compliance.

• Prior experience in Class IV medical device companies.

• Experience with international regulatory approvals.