Position Summary
Experienced Quality Assurance professional with 5-7 years in the medical device industry, focused on audit response, CAPA, validation, and document control within ISO 13485-compliant environments.
Duties and Responsibilities
- Prepare and maintain the quality system in a state of audit readiness.
- Lead internal preparation and documentation support for regulatory, customer, and certification audits (e.g., ISO 13485/cGMP/MDSAP/IVDR/WHO PQ).
- Respond to auditor inquiries and ensure timely resolution of findings.
- Manage the full lifecycle of Corrective and Preventive Actions (CAPA), including root cause analysis, implementation of corrective actions, effectiveness checks, and documentation.
- Collaborate with cross-functional teams to ensure long-term compliance and quality improvements.
- Lead and coordinate equipment, process, and software validation activities.
- Ensure proper planning, protocol development, execution, deviation handling,
and reporting are in compliance with regulatory requirements and internal procedures.
- Oversee creation, revision, approval, and archiving of controlled documents including SOPs, work instructions, forms, and quality records.
- Ensure alignment with document control policies and support training on new or revised procedures.
- Support the implementation and monitoring of QMS elements (ISO 13485).
- Lead quality initiatives and gap assessments, and drive continuous improvement through internal audits, KPI monitoring, and quality review meetings.
Qualifications
- Bachelor's degree in Biomedical Engineering, Biotechnology, or a related field in life sciences or engineering
- Minimum of 57 years experience in Quality Assurance within the medical device or pharmaceutical industry, including audit preparation, nonconformance handling, and quality system maintenance
Knowledge, Skills, and Abilities
- ISO 13485 Internal Auditor certification (preferred)
- RCC-MDR or equivalent regulatory training (preferred)
- English and Korean bilingual (preferred)
-- In-depth understanding of ISO 13485 and QMS requirements
- Experience with CAPA systems, validation protocols (IQ/OQ/PQ), and document control procedures
- Strong attention to detail
- Problem-solving mindset
- Effective communication and documentation skills
- Ability to work in cross-functional teams
