About the job Team Manager of Quality Assurance Position SummaryExperienced 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 maintenanceKnowledge, 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
DHD Consulting