Sr. QA specialist

Job description

[About ZEISS] The ZEISS group is a Global Leader in Optical Technology with a 180-year history. The ZEISS Group, headquartered in Oberkochen, Germany, provides innovative solutions in semiconductor technology, industrial quality and research, medical technology and consumer optical technology. The history of the ZEISS group, which began with the founder of Carl Zeiss in 1846 based on the entrepreneurial spirit of “combining theory and practice”, has established itself as a pioneer in the field of optics through ceaseless exploration of the field of optics. ZEISS Korea has played a key role in the Korean market for the past 40 years. For ZEISS, the Korean Market is One of the Top 5 Global Sales Markets, providing products and services from five business areas to Korean customers: Semiconductor Manufacturing Technology Industrial Quality Solutions Research Microscopy Solutions Medical Technology Vision Care (Consumer Markets) [Employement Conditions] ㆍDivision: Medical Technology (의료기기사업부) ㆍJob Title: Sr. QA specialist ㆍContract: Regular ㆍLocation: Seoul Overview: Reporting to the SSC Korea RAQA Team Leader, the Sr. QA specialist is responsible for establishing and maintaining the Quality Management System (QMS) in accordance with MFDS regulations and internal quality standards. This role ensures product safety and compliance by leading complaint management, maintaining KGMP/DGMP certifications, overseeing UDI system compliance, and managing the quality assurance framework for used medical devices to align with global and local business strategies. Key responsibilities: - Quality Management System (QMS) Management Develop and maintain the Quality Management System in compliance with MFDS regulatory and internal requirements. Support QMS documentation to ensure alignment with Headquarter (HQ) and SSC Korea strategies. - Labeling and Unique Device Identification (UDI) Management Drive the registration and maintenance of labeling and UDI data to ensure compliance with MFDS regulations. Partner with the Supply Chain team to secure accurate barcoding, labeling alignment, and system integration for labeling compliance and end-to-end product traceability. - Complaint Handling & Vigilance Manage the full lifecycle of product complaints, including initial intake and reporting to appropriate manufacturing sites. Follow up on complaint investigations, coordinate product returns, and ensure timely adverse event reporting to the MFDS. - Quality Records & Product Release Prepare and manage Quality Records for product inspection, import, and release processes. Monitor quality assessments for returned products and ensure documentation meets compliance standards. - Field Actions & Recalls Implement Quality Holds as necessary to prevent the distribution of non-conforming products. Collaborate closely with manufacturing site QA and RA teams to execute field actions and recalls effectively. - KGMP/DGMP Certification Management Work proactively with manufacturing sites to maintain and renew KGMP/DGMP certificates. Ensure all site-related information is updated and compliant with local regulatory expectations. - Quality performance monitoring of 3PL Monitoring quality compliance levels of contracted 3PL based on the Quality Agreement. Track and report on quality performance metrics to ensure continuous improvement. - Training & Stakeholder Management Conduct quality training for internal and external stake holders, specifically regarding the complaint handling process to meet local requirements. Qualifications: - Experience: Minimum of 6 to 10 years of professional RA/QA experience within the medical device industry. - Education: Bachelor’s degree in Medical Engineering, Biomedical Science, or a related field is preferred. - Knowledge & Expertise : Comprehensive knowledge of MFDS regulations, KGMP/DGMP compliance, and ISO 13485 standards. Demonstrated ability to oversee quality assurance regulations and post-market vigilance for new, used, and refurbished medical devices. Extensive experience leading internal/external audits and representing the company during regulatory inspections. - Language: Fluent or professional proficiency in both Korean and English, with a proven ability to lead communication and negotiations with local authorities and global stakeholders. - Skills: Exceptional analytical, problem-solving, and risk-management capabilities. Advanced cross-functional communication and stakeholder management skills to align internal teams and external partners. Proven ability to drive projects independently with a strong sense of ownership and high accountability. Your ZEISS Recruiting Team: KyuYul Jung （정규열）, ShinBi Park （박신비）