Sr. Quality Assurance Specialist
Other service activities
Healthcare & Therapy
About Company:
Job Title
Sr. Quality Assurance Specialist
Location
Seoul, South Korea
About our Client
A leading global dental technology compan
Role Summary
Our client is seeking a Senior QA Specialist / QA Specialist to manage the Quality Management System (QMS) for Korea and ensure compliance with MFDS regulations, KGMP requirements, and global quality standards. This role will lead quality activities including audits, inspections, supplier quality management, change control, CAPA, and distribution oversight while serving as the primary quality representative for Korea.
Key Competencies:
Key Responsibilities:
1. Quality Management System (QMS)
· Own, maintain, and continuously improve the Quality Management System (QMS) for Korea operations.
· Ensure compliance with local regulatory requirements, KGMP standards, and global quality policies.
· Develop, review, update, and implement quality procedures, processes, and documentation.
· Identify process improvement opportunities and implement corrective actions to strengthen QMS effectiveness.
· Provide quality-related training and documentation support to internal stakeholders.
· Advise on quality aspects of systems, equipment, suppliers, and operational processes.
2. Audit & Inspection Management
· Serve as the company representative during MFDS/KGMP inspections.
· Lead and coordinate inspection readiness activities and responses with cross-functional teams.
· Drive CAPA activities arising from inspection findings or regulatory observations.
· Plan and execute internal quality audits for Korea operations.
· Host and manage external quality audits conducted by partners, suppliers, or regulatory authorities.
3. Quality Operations
· Develop and execute the annual quality plan for Korea operations.
· Monitor quality metrics and provide regular reports to regional and global quality leadership.
· Manage change control activities and ensure appropriate quality oversight.
· Lead nonconformance investigations and CAPA processes to ensure timely closure.
· Represent Quality Assurance in global and regional projects involving Korea deployment.
· Support quality compliance activities for new initiatives, product launches, and other ad hoc projects.
4. Quality Oversight of Product Distribution & Supplier Management
· Ensure products are imported, stored, tested, released, and distributed in accordance with applicable regulatory requirements.
· Oversee quality compliance of external logistics providers, distributors, and third-party suppliers.
· Establish and maintain a risk-based supplier qualification and governance framework.
· Conduct supplier audits (onsite and remote) and monitor supplier performance.
· Review and approve supplier CAPA plans and verify effectiveness of corrective actions.
· Act as the final quality authority for compliance-related decisions, ensuring objective and evidence-based assessments.
An Ideal Candidate:
Qualifications:
· Bachelor's degree or above in Science, Engineering, Pharmacy, Life Sciences, or a related discipline preferred.
· Minimum 5 years of Quality Assurance experience within the medical device, pharmaceutical, healthcare, or food industry.
· Hands-on experience managing KGMP inspections is required.
· Strong experience in developing, implementing, and maintaining Quality Management Systems (QMS).
· Experience with supplier quality management, audits, CAPA, and change control processes preferred.
· Experience working within a multinational or highly regulated environment is advantageous.
· Fluent Korean and English communication skills, both written and verbal.
Contact
May Lwin | Permanent Consultant
Healthcare & LifeSciences Team
02-6200-9787
Ref: JN-082026-206008