Quality Assurance Specialist

Description

• Management of quality documentation (Quality Manual, Procedures, PMF, Local Language Label, etc)
• ISO 13485/MFDS/Corporate audit
• CAPA & Risk management
• Supplier management
• Quality release of repaired products
• Complaint handling and follow-up in Korea
• Assess the reportability of global complaints and report foreign adverse events to MFDS
• Field action including recall activity, quality hold, issue evaluation, etc
• PMS data collection for license renewal and reevaluation
• Maintenance of KGMP certificates, including on-site audits and document audits
• UDI registration and maintenance, and Monthly supply report
• Track and follow up on the new regulations/requirements

Qualifications

• Bachelor’s Degree in life sciences, technical (engineering), or related field; advanced degree strongly preferred
• Minimum of 3-4 years of experience required in Quality Assurance
• Certifications are an advantage, including Regulatory Affairs (RAC), Quality Auditor, and NIDS RAC