Purpose:
61 Lead, facilitate, improve CAPA process and drive CAPA activities from issue identification to closure.
61 Maintain and manage an effective CAPA system to meet the requirements of appropriate global regulations and standards, such as US 21 CFR Part 820/ QMSR, ISO 13485 and ISO 14971 etc.

You are responsible for
61 Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.
61 Keep communication with Philips global/Central CAPA community (CoP/CoE) and deploy CAPA strategy/policy.
61 Project manage all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.
61 Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.
61 Managing site CAPA program and leading CAPA Review Board meetings.
61 Lead and mentor CAPA owners and cross functional teams to perform CAPA activities.
61 Coordinate CAPA presenting during audits.
61 Maintain and manage the CAPA tool (e.g. Trackwise).
61 Lead PQMS transition/standardization project and QMS activities from project.
61 Lead the upgrading and continuous improvement of QMS processes to ensure compliance and effectiveness.
61 Assist in QMS training to enhance compliance/quality mindset and training administration arrangement to meet business needs.
To succeed in this role, you should have the following skills and experience
61 Education: Bachelor’s Degree or above (with a pharmaceutic or medical device background or similar is preferred)
61 Experience: A minimum of 5 years’ experience in a quality system/regulatory environment, at least 3 years in medical industry.
61 Competency and Skills：
61 Knowledge in the areas of medical device, change control, CAPA, QMS audit and QMS process risk management.
61 Good understanding of ISO9001/ISO13485/21 CFR Part 820 management system and total quality management concept.
61 Effective interpersonal and communication skills, detailed minded and able to work under pressure.
61 Fluent written and spoken English and Chinese.
61 Teamwork spirit.