Location: Seoul, Korea, Republic of
Position Type: Unfixed Term
The Quality Specialist and/or Quality & Vigilance Expert will be responsible for managing the Quality Management System aspects of the products being imported into Korea site for all business within bioMerieux Korea Co., Ltd.
In addition to providing oversight, the role will be required to carryout the following Responsibilities for Quality to ensure compliance with the applicable Korea regulations requirements, post-market surveillance and other compliance activities (e.g., ISO 9001:2015).
• Quality Documents, Records and labelings managements which related to bioMerieux Korea handled products under Quality Management System (QMS)
• Communicate and liaise with global and regional staffs
• Perform the post-market surveillance activities (Adverse Event reporting, Field Actions, Product Recall, Quality Holds, etc.) in accordance with internal process and comply with the Korea regulations
• Maintain compliance for imported In-vitro Diagnostic (IVD) medical devices/ medical devices per the Quality Management System in compliance with Korea regulatory requirements and internal policy/process/procedures
• Perform the distributor and supplier management as a part of QMS to comply with internal process
• Maintain KGMP certification including KGMP on-site inspection/audit to foreign manufacturing sites
• Involve the customer complaints handling process as a quality aspects. Initiate/following up on complaint investigation & RCA (Root Cause Analysis). If needed, preparing customer response letter in the local language
• Manage the non-conformity (NC) and execute the CAPA (Corrective Action and Preventive Action)
• Participate and follow up for regular internal & corporate audits, regular/random (unannounced) external audit and regulatory authority inspections
• Bachelor’s Degree in Biology, Bioengineering, Biomedical/laboratory science, medical device/engineering related background.
• At least 5 year’s working experiences in the healthcare industry. Preferred 2 years working experience in quality/regulatory role at the international or manufacturing companies in the related industry. Or equivalent work experience in the IVD (In-Vitro Diagnostic) Medical Device industry
• Good problem solving and communication skills
• Knowledge of applicable local regulations, industry standard and GMP (Good Manufacturing Practice). Good understanding of quality management system principles practical experience of implementing effective quality procedures
• Independent, proactive and able to work in a matrix environment
• Must have a written and verbal communication skills in English
• Able to business travel (Domestic and international)
• Experience of conducting and/or participating in the internal and/or external (notify body and Regulatory Authority, etc.) audits is preferred