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Responsibility in the position:
主要工作職責：
· Perform supplier quality system audit.
· Supplier corrective action report follow up
· Handle NCR and CA/PA and be able to support the organization in NCR and CA/PA handling.
· NCR and CAPA management, verification and validation of Corrective And Preventive Action (CAPA) taken。
· Process quality problem handling & process improvement.
· Establish and manage an effective Calibration Program for test, monitoring and measuring equipment.
· Perform data trend analysis and report to QA & RA Manager.
· As deviation change analyst to handle deviation in Agile and be able to support the organization deviation handling.
· Analyse and review changes arisen from Agile as per Agile Change Analyst role.
· Work collaboratively with Ambu A/S on Agile administration as Agile coordinator in Ambu Ltd.
· Documentation issuance and receipt, obsoleted document management and maintenance. Establishment and management of Bill of Materials in MOVEX system.
· Conduct NEO training to new comers and conduct in-house training as Agile expert.
· Assist the QA&RA Manager in all types of audits, and lead the audit as Audit Coordinators.
· Assist QA & RA Manager to ensure compliance to the latest version of ISO9001, ISO13485, 21 CFR 820, Chinese GMP and CE standards.
· Assist QA&RA Manager to promote awareness of our QMS, Customer and Regulatory requirements in the daily work and live up to our ABC values.
· Assistant superior for daily business
Preferred Competency(s):
· Bachelor’s Degree in any science discipline (Electronic with camera/screen work experience is preferred)
· Have experience from the medical industry and at least a basic knowledge of ISO9001, FDA QSR (21 CFR 820), ISO 13485 standards and Chinese GMP.
· Have at least a basic knowledge in statistical methods
· Good English speaking & writing skills
· Good knowledge in validation requirements
· Basic knowledge of validation / process validation
· Basic knowledge of Product, Process, QC tools, RCA, Risk Management, Design control, Sterilization technology.
· Certified lead auditor (preferably)
· Certified internal auditor per ISO 13485/9001 will be a plus
· Familiar with MS Office, eg. Excel, Word and Power Point
· Independent, resourceful, creative, dynamic, result driven and a good team player
· Pro-active, with good communication skill, leadership skill, problem solving, and analytical skill