CAPA Quality Engineer

Elyon International•Murrysville, PA

About The Position

These critical resources are being added to support the injunction lift and getting the CAPA program back to a healthy state. The CAPA Quality Engineer will facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring. This role will 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. The engineer will represent CAPAs during audits and CAPA Review Board meetings, and lead and mentor cross functional teams with the implementation of appropriate root cause analysis techniques. They will analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances, and 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. The engineer will independently produce and complete CAPA records, and be 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. The role requires the ability to understand and analyze complex problems, including software and hardware design issues, and demonstrate knowledge of tools and techniques required to perform thorough root cause analysis and develop strong investigations. A 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 is essential. The position also requires the ability to partner with the business and effectively interact with and influence employees, and managers on all levels, and possess strong Project Management skills, including the ability to project manage all CAPA activities. The engineer will be 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.

Requirements

Bachelor’s engineering degree with > 5 years of related experience, or a Master’s degree with > 3 years of related experience.
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.
Excellent written and verbal communication skills

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 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 (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.
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.