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

Questions to ask:

1. Experience and Background:
o What experience do you have with quality assurance and control processes in the medical device industry?
o Can you describe a time when you identified an issue in the production process that could have caused product defects?
2. Regulatory Knowledge:
o How familiar are you with the regulations and standards that apply to medical devices, such as ISO 13485 or FDA regulations?
o Have you ever conducted clinical trials or other research studies related to medical devices?
3. Problem-Solving and Analysis:
o Explain your understanding of root cause analysis and how it can be used to identify and address issues in the production process.
o What methods do you use to measure and monitor the performance of quality control processes?
4. Quality Management Systems:
o Are you familiar with any quality management systems such as ISO 9001 or Six Sigma?
o What strategies do you use to develop and implement effective quality control procedures?

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