CAPA Quality Engineer

Job Responsibilities:

• 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 Producing 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 (Corrective and Preventive Action) 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.
• Able to understand and analyze complex problems, including software and hardware design issues.
• Demonstrated knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations.
• Strong understanding of appropriate global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971.
• 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.

Job Family Description:

• Excellent written and verbal communication skills
• Responsible for leading CAPA engineering activities like: assessing complex investigations and corrective actions and reviewing test and other complex performance data, leading complex root cause analysis and complex quality problem solving.
• Bachelors engineering degree with > 5 years of related experience, or a Masters degree with > 3 years of related experience.

Position Details:

• These critical resources are being added to support the injunction lift and getting the CAPA program back to a healthy state.