Easter Seals Jobs

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.

• Support the upgrading and continuous improvement of QMS processes to ensure compliance and effectiveness.

• Assist in enhancing compliance/quality mindset and administration arrangement to meet business needs.

You are responsible for

• 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, include but not limited to:

• Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances.

• • Implementation of appropriate root cause analysis techniques (e.g. Pride problem solving).
• • Perform detailed CAPA engineering tasks like assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving.
• • Produce and completes CAPA records timely in all required elements and best practices of CAPA.
• • Coordinate CAPA presenting during audits.
• • Maintain and manage the CAPA tool (e.g. Trackwise).

• Take role of site local SME for NPSS process and contact window for QMS relative system software, maintain the validation list of QMS relative system software, keep communication with relative SQA and coordinate with local users, to ensure the queries about NPSS validation could be responded timely.

• Contributes to PQMS transition/standardization project and QMS activities from project.

• Contributes to 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.

• Support other QMS activities, e.g. external/internal audit, Management Review, KPI review and

• monitoring, NPSS, etc.

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 3-year experience in a quality system/regulatory environment.

• Competency and Skills：

• Knowledge in the areas of medical device, change control, CAPA, audit and 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.