Quality Assurance Manager

Job Title

Quality Assurance Manager

Location              

Seoul, Korea

About our Client

A Global Leader in Medical Technology and Innovative Healthcare Solutions

Key Responsibilities

• Regulatory Compliance & Oversight: Ensure the company adheres to MFDS regulations and manage QA operations related to post-market activities, including product labeling, importation requirements, and QMS maintenance.
• Maintain ISO Certification: Oversee the continued compliance and maintenance of company’s ISO certification.
• Audit Leadership: Serve as the primary point of contact during Corporate Quality Audits and external inspections, ensuring successful audit outcomes and compliance.
• Quality Assurance Activities: Lead and collaborate with cross-functional teams to conduct internal audits, supplier audits, CAPA (Corrective and Preventive Actions), customer surveys, product validation, Quality Management Review meetings, and supplier performance management. Ensure that the most up-to-date quality documentation is utilized, and all quality records are properly maintained.
• 3PL Oversight: Supervise the quality management systems of third-party logistics (3PL) providers to ensure they meet both internal and external standards.
• KGMP Certification: Take responsibility for the renewal of KGMP certification for the company’s overseas manufacturers, working closely with Regulatory Affairs (RA).
• Quality Projects: Lead and actively contribute to key Quality Assurance projects required by the company’s entities in Korea, East Asia, Corporate, and across Divisions.
• Regulatory Advocacy: Actively engage with regulatory authorities to advocate for the company and the broader industry, contributing to the development and shaping of regulatory policies.
• Collaboration & Education: Educate and work closely with internal teams (commercial, functional departments) and customers to address quality-related issues and ensure compliance with company standards.

Key Requirements

• Education: Bachelor’s degree in a relevant field (Science, Engineering, Medicine, Law, etc.).
• Experience: Minimum of 8 years of experience in Regulatory Affairs and Quality Assurance within the healthcare industry.
• Language Skills: Strong professional communication skills in English (both written and verbal).
• Highly organized with strategic thinking and excellent planning abilities.
• Detail-oriented with a strong sense of responsibility and commitment.
• Proactive, punctual, and disciplined in managing tasks and responsibilities.
• Demonstrated team management experience, with the ability to lead and mentor a team effectively.

Contact

May Lwin, Permanent Associate Consultant

02 6200 9787

May.Lwin@adecco.com