Purpose:

• Responsible for driving CAPA activities from issue identification to closure, effectively project managing all CAPA activities, ensuring the quality of CAPA record content and representing CAPAs during audits and CAPA Review Board meetings.

• Maintain and manage an effective CAPA system to meet the requirements of appropriate global regulations and standards such as China NMPA GMP, US 21 CFR Part 820/ QMSR, JPAL regulation MHLW169, Brazil ANVISA GMP (RDC665), ISO 13485/ GB/T42061 and ISO 14971/ GB/T 42062.

Your role:

• Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.

• 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.

• Represent CAPAs during audits and CAPA Review Board meetings.

• Lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques (e.g. Pride problem solving).

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

• 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.

• Independently produces and completes CAPA records. Responsible for performing timely, detailed CAPA engineering tasks like: assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving.

• Maintain and manage the CAPA tool (e.g. Trackwise).

• Complete other tasks assigned by manager.

You're the right fit if:

• Education: Bachelor’s degree in an engineering or scientific-related field or equivalent demonstrated strong technical competence.

• Experience: 3+ years. of related experience in medical device or other regulated industry.

• Competency and Skills:

• Developing professional expertise, applies company policies and procedures to resolve a variety of issues.

• Has working knowledge of company products and services. Frequently interacts with cross functional teams. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules.

• Able to understand and analyze complex problems.

• Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations.

• Working knowledge of appropriate global regulations and standards such as China NMPA GMP, US 21 CFR Part 820/ QMSR, JPAL regulation MHLW169, Brazil ANVISA GMP (RDC665), ISO 13485/ GB/T42061 and ISO 14971/ GB/T 42062.

• Demonstrated ability to partner with the business and effectively interact with and influence employees, and managers on all levels.

• Strong Project Management skills, including ability to project manage all CAPA activities.

• Ability to analyze data and apply statistical techniques.

• Excellent written and verbal communication skills.