Sr. QA Specialist

Position summary:

Primarily responsible for execution of the post market surveillance activities and support of the quality management system in accordance with relevant regulatory requirements and corporate requirements of medical devices.

Oversee, support, and ensure that an effective and efficient post market surveillance is built and maintained. Responsibility for ensuring that all post market surveillance regulations are met in compliance.

Develop, support and ensure building up quality process, procedures and legislations.

Essential duties & responsibilities:

1. PMS System Management

- Implement and maintain the company’s PMS system in alignment with global and local regulatory requirements.

- Establish risk-based PMS procedures and meet the quality KPIs across product lines.

- Ensure PMS data is integrated into the QMS, risk management, and product improvement processes.

2. Complaint Handling, Reporting, and Monitoring

- Initiate and manage the end-to-end complaint handling process, including intake, product returns, communication with customers, and coordination with multiple stakeholders.

- Ensure complaints are appropriately escalated based on severity and regulatory timelines.

- Communicate with global manufacturers to support technical investigations and implement corrective actions.

3. Vigilance & Regulatory Reporting

- Ensure timely and accurate vigilance reporting to regulatory authorities, such as the MFDS, according to the product portfolio.

- Manage reportable events, field safety notices, and mandatory regulatory submissions.

- Oversee timely PMS reporting, including adverse events (AEs), foreign matters, and other relevant cases.

- Maintain compliance with country-specific reporting requirements and documentation standards.

- Provide PMS findings to Risk Management and RA/QA teams to update risk files and product documentation.

4. Field Actions & Recalls

- Support the coordination and execution of field corrective actions and product recalls.

- Communicate with global teams, regulatory authorities, distributors, and customers as needed.

- Ensure accurate documentation and timely closure of all field action activities.

5. KGMP (Korea Good Manufacturing Practice) Responsibilities

- Coordinate with global manufacturers to ensure compliance with KGMP requirements.

- Manage KGMP certification and renewal processes, and support onsite audits for imported medical devices.

- Ensure KGMP compliance, including documentation control, risk management, and quality system updates.

- Serve as the primary contact for the MFDS and third-party auditors regarding KGMP compliance matters.

6. Cross-Functional Collaboration

- Work closely with Regulatory Affairs, Quality Assurance, Service, Supply Chain, and Global PMS teams.

- Provide PMS insights to support product lifecycle management, labeling decisions, and design improvements.

- Support internal/external audits and regulatory inspections related to PMS.

- Work with warehouse and logistics teams to ensure KGMP-compliant environmental control and product handling.

7. Others

-Maintain clear and well-organized documentation for all PMS activities.

-Manage quality-related data, including COCs, COSs, quality agreements, and other relevant documents.

Qualifications & experience:

- Bachelor’s degree in Life Sciences, Biomedical Engineering, or a related field.

- 4–5 years of experience in medical device QA/RA, with at least 3–5 years focused on PMS.

- Experience with KGMP, including both documentation and onsite audits, is preferred.

- Strong knowledge of regulations and global vigilance requirements.

- Experience managing complaints, field actions, trend analysis, and regulatory submissions.

- Excellent analytical, communication, and cross-functional collaboration skills.

- Preferred: Fluent in English; Korean proficiency is an advantage for Korea-based roles.