18160 QA&RA Manager
・Create and perform Local management review meetings.
・Moderate local management review meetings.
・Arrange, prepare, moderate and ensure follow-up for monthly QIT meetings
・Archive MoM from QIT
・Review status of Sales Force issue cases
・Track status of complaints
・Provide necessary QARA related supports to the local business.
・Advise the local management and local team regarding the business from the point of QARA.
・Screen, monitor and keep the latest local requirements (include applicable industry regulations and standards) which are relevant to the company business
・Ensure compliance with local regulatory requirements, applicable industry regulations and standards.
・Cooperate with the safety officer for supplying to the Safety Control General Division with information on the safety assurance measures specified by the GVP
・Ensure the maintenance of applicable business licenses which are required by the relevant local regulations.
・Support Marketing team regarding the product registration and homologation strategy under compliance with local requirements.
・As appropriate implementation and lead of local document control according to local requirements and legal requirements, e.g. ISO 13485
・Train employees regarding GDP regarding process requirements if needed.
・Moderate meetings on a local level to inform about revisions or new documents if needed.
・Maintain local overview of QMS documentations.
・Implement local change management process inclusive of tracking, monitoring and escalation of (overdue) change requests.
・Participate, and moderate local and global change board meetings as appropriate.
・Perform review and QM approval of revisions or new documents
・Archive quality relevant records
・Maintain local Quality Index
・Review local QMS docs regarding Doc Con and GDP requirements
【Corrective Action & Preventive Action】
・Ensure local implementation of the global CAPA system according to regulatory requirements
・Review CAPA and MIR(Manufacturer Incident Report) Reports
・Train employees on CAPA topics (RCA,…) if needed
・Implement and to moderate workshops to achieve improvement in regards to corrective and preventive actions if needed
・Analyze CAPA status, to monitor KPIs and perform data analysis (QIT, MRB, KPIs, etc)
・Work on global CAPA checks
・Monitoring and escalation if needed for CAPAs, MIRs, global checks
・Support in the maintenance of the CAPA and MIR log in case of updates
・Share local CAPAs and MIRs with global CAPA Officer or CAPA Board to discuss RCA or actions if needed
・Provide evidences for implemented actions
・Local implementation of the training concept according to global requirements, additional local regulatory requirements and according to ISO13485
・Train admins on training tool
・Maintain data together with admins by informing about training roles
・Analyze training status, to monitor KPIs / data analysis
・Inform of QMS training needs
・Review CAPAs with training issues and to ensure continuous improvement based on lessons learned.
・Archive quality relevant training records if needed
・Inform about new hires, colleagues leaving company or in case of role changes
・Maintaining local training matrix
・Tracking & documenting training status (e.g. Power BI)
・Follow up on training status
・Maintain the internal e-learning administration system to ensure that all employees take necessary e-learnings regarding QMS.
・Prepare and to participate during internal and external audits (QMS)
・At least 3 years experience in ISO implementation or similar standards
・At least 3 years experience in quality assurance duties or equivalent or competence in the proper and smooth conduct of the quality control duties in Japan
・Experiences in medical device industry
【Knowledge & Skill】
・Process Management Skills
・Cross functional communication skills
・Presentation and Training Capabilities
・Statistical Analysis, Six Sigma or similar
・Reading & witting English skills are mandatory. Fluent verbal communication is not required.