Responsibility in the position:

主要工作职责：

· 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