CAPA Quality Engineers

Katalyst CRO; Murrysville (Westmoreland County); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO in the United States seeks a senior CAPA Engineer to lead corrective and preventive actions across product and process improvements within a regulated medical device environment.

You will drive complex CAPA investigations, mentor cross-functional teams, manage projects end-to-end, and ensure compliance with 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001 and ISO 14971.

Qualifications

• CAPA investigations from issue identification through solution and effectiveness monitoring.
• Project manage CAPA activities with cross-functional resources and timelines.
• Represent CAPAs during audits and CAPA Review Board meetings.
• Lead and mentor cross functional teams with root cause analysis techniques.
• Analyze quality monitoring data and apply statistical methods to identify causes of non-conformances.
• Collaborate with management to ensure CAPA plans have required resources and cost support.
• Independently produce CAPA records and complete CAPA tasks.

Responsibilities

• Facilitate CAPA investigations from issue identification through implementation and monitoring.
• Project manage CAPA activities with cross-functional teams and timelines.
• Represent CAPA activities during audits and CAPA Review Board meetings.
• Lead and mentor teams in root cause analysis techniques.
• Analyze quality data to identify and address non-conformances.
• Ensure management supports CAPA action plans with needed resources.

Skills

CAPA leadership

Root cause analysis

Statistical methods

Project management

Cross-functional teamwork

Education

Bachelor's in Engineering

Master's in Engineering

Job description

• These critical resources are being added to support the injunction lift and getting the CAPA program back to a healthy state.
• 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.
• Bachelor's engineering degree with 7+ years of related experience (strong Med Device), or a master's degree with 5+ 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.
• 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.
• Bachelor's engineering degree with 7+ years of related experience (strong Med Device), or a master's degree with 5+ years of related experience.

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 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.

Notes

• 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.