DHD Consulting
About the job Team Manager of Quality Assurance
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
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