[회사소개]
외국계 메이저 의료기기업체

[모집부문]
당뇨사업부 QA Specialist

[담당업무]
• Play a key role in facilitating the communication of Adverse Events (AEs) to the Korean Regulator (MFDS).
• Support the preparation and execution of KGMP audits (new, renewal), including coordination of documentation from manufacturing sites, review of audit materials, preparation of submission packages, and facilitation of internal alignment to meet MFDS expectations. Assist in the organization of audit schedules, pre audit readiness checks, and follow up activities.
• When quality gaps are identified, and Corrective and Preventive Actions (CAPA) are required, support investigations & root cause analysis, supporting the development & implementation of appropriate corrective/ preventative actions. Ensure CAPAs identified during audits or other means are successfully resolved prior to committed due dates.
• Act as the main Document control and training admin for the local quality system, supporting the creation, revision, obsoletion, management of training assignment & periodic review of documentation.
• Support the evaluation & quality management of internal & external suppliers.
• Assist QA Manager Korea to manage the internal auditing program, including but not limited to the development of internal schedules, performance of process auditing activities, and efficiently support of resulting actions.
• Play a major role in the tracking and trending of quality department key performance indicators, to allow efficient oversight of the local quality system. The status report will include current projected completion dates and will be updated and published as required / when status changes.
• Establish effective partnerships within the business locations to ensure QA needs are identified and successfully met. Support manufacturing site requests (e.g., quality holds, reworks, complaint product returns).
• The position will require the incumbent to build effective relationships with local departmental representatives, Regulatory body representative, etc

[자격요건]

• (4-5+ years) in a QA Role within the Medical device, Pharmaceutical or related industry experience.
• Experience in the handling of adverse event for reporting purposes.
• Experience in corrective action & preventative action problem-solving methodologies, including root cause analysis.
• Ability to develop procedures and policies that clearly define efficient and effective processes needed to ensure compliance and resolve identified problem.
• Strong Knowledge of ISO 9001 and especially ISO 13485 Standards is preferred.
• Must possess a high degree of responsibility and deep sense of ownership for ensuring the highest level for QA standards.
• Experience in document control & training management.
• Knowledge of change management & risk assessment is preferred.
• Experience in leading and participating in cross-functional teams tasked with QA problem resolution.
• Experience in training curriculum development is preferred.
• Experience in external supplier quality management is preferred.
• Knowledge of internal audit program management.
• Proficiency in Microsoft Office software (i.e., Word, Excel, and PowerPoint).
• Ability to communicate fluently/effectively in spoken and written English.