This position is essential to driving CAPA activities from issue identification closure, project manage CAPA activities, ensuring the quality of CAPA record content and representing CAPAs during audits and CAPA review board meetings. Position to be home based in the USA. 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.
Screening Questions and Answers:
1. What does CAPA stand for, and why is it important in the medical device industry?
o CAPA stands for Corrective and Preventive Actions. It is crucial in the medical device industry to identify and eliminate the root causes of non-conformities and prevent their recurrence, ensuring product quality and regulatory compliance.
1. Can you explain the difference between corrective actions and preventive actions?
o Corrective actions address existing issues by identifying and eliminating the root cause of a non-conformity. Preventive actions are proactive measures taken to prevent potential issues from occurring.
1. Process and Implementation
1. What are the typical steps involved in a CAPA process?
o The typical steps include: identifying the issue, conducting a root cause analysis, developing a corrective/preventive action plan, implementing the actions, verifying the effectiveness, and documenting the entire process.
1. How do you identify when a CAPA is needed?
o A CAPA is needed when there is a significant non-conformity, customer complaint, audit finding, or any other indication of a systemic issue that could impact product quality or regulatory compliance.
1. What tools or methods do you use for root cause analysis in CAPA investigations?
o Common tools include the 5 Whys, Fishbone (Ishikawa) Diagram, Failure Mode and Effects Analysis (FMEA), and Pareto Analysis.
1. Regulatory Compliance
1. Which regulatory standards and guidelines must CAPA processes comply with in the medical device industry?
o CAPA processes must comply with FDAs 21 CFR Part 820 (Quality System Regulation) and ISO 13485 (Medical devices Quality management systems).
1. How do you ensure that CAPA activities meet FDA and ISO 13485 requirements?
o By following a structured CAPA process, maintaining thorough documentation, conducting regular audits, and ensuring all actions are traceable and verifiable.
1. Practical Application
1. Can you provide an example of a CAPA you have managed, including the issue, investigation, and resolution?
o Example: A non-conformity was identified in a batch of medical devices due to a manufacturing defect. A root cause analysis revealed a malfunctioning piece of equipment. The corrective action involved repairing the equipment and retraining staff. The preventive action included implementing regular maintenance checks. The effectiveness was verified through subsequent batch testing.
1. How do you verify the effectiveness of a CAPA once it has been implemented?
o By monitoring the process or product for recurrence of the issue, conducting follow-up audits, and reviewing performance data to ensure the issue has been resolved and does not reoccur.
1. Continuous Improvement
1. What role does CAPA play in continuous improvement within a quality management system?
o CAPA is integral to continuous improvement as it systematically addresses and eliminates root causes of issues, leading to enhanced product quality and compliance over time.
1. How do you document and track CAPA activities to ensure ongoing compliance and improvement?
o CAPA activities are documented in a CAPA management system, which includes detailed records of the issue, investigation, actions taken, verification of effectiveness, and any follow-up actions. Regular reviews and audits ensure ongoing compliance and improvement.
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* Bachelor's degree plus a minimum of 3+ years in a highly regulated environment as an engineer that has done CAPA's as part of their day to day job (auto, pharma, nuclear industries)
* Understanding and application of global medical device regulations
* Experience in Quality Management System processes (ISO 13485), including cross-sector or business process standardization, ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations
* An ability to successfully communicate and educate quality management system regulations, policies, and strategies to teams at all levels of the organization
* Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.
* Advanced Analytical Skills; demonstrated ability to troubleshoot complex process/system issues
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.