Philips CAPA Manager 

China, Guangdong Province 

355447940

CAPA Manager

Purpose:

• Lead, facilitate, improve CAPA process and drive CAPA activities from issue identification to closure.
• 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.

• Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.
• Keep communication with Philips global/Central CAPA community (CoP/CoE) and deploy CAPA strategy/policy.
• 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.
• 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.
• Managing site CAPA program and leading CAPA Review Board meetings.
• Lead and mentor CAPA owners and cross functional teams to perform CAPA activities.
• Coordinate CAPA presenting during audits.
• Maintain and manage the CAPA tool (e.g. Trackwise).
• Lead PQMS transition/standardization project and QMS activities from project.
• Lead the upgrading and continuous improvement of QMS processes to ensure compliance and effectiveness.
• 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

• Education: Bachelor’s Degree or above (with a pharmaceutic or medical device background or similar is preferred)
• Experience: A minimum of 5 years’ experience in a quality system/regulatory environment, at least 3 years in medical industry.
• Competency and Skills：
• Knowledge in the areas of medical device, change control, CAPA, QMS audit and QMS process risk management.
• Good understanding of ISO9001/ISO13485/21 CFR Part 820 management system and total quality management concept.
• Effective interpersonal and communication skills, detailed minded and able to work under pressure.
• Fluent written and spoken English and Chinese.
• Teamwork spirit.

Why should you join Philips?

• Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by .

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