CAPA Quality Engineers

Katalyst CRO; Murrysville (Westmoreland County); On-site; USD 80,000 - 100,000; Full time

Job summary

Katalyst CRO is seeking a CAPA Engineer to lead essential CAPA engineering activities and oversee corrective actions in Murrysville, PA. The ideal candidate will have a Bachelor's degree in Engineering along with over 7 years of related experience, preferably in the Medical Device sector.

This role requires a strong understanding of global regulations such as ISO 13485 and the ability to effectively manage CAPA activities, ensuring timely and effective solutions to quality issues.

Qualifications

• 7+ years of related experience in Medical Device industry.
• Strong knowledge of global regulations including ISO 13485 and 21 CFR.

Responsibilities

• Facilitate CAPA investigations and monitor effectiveness.
• Project manage CAPA activities and team commitments.
• Lead root cause analysis and quality problem solving.
• Analyze quality data and identify non-conformance causes.

Skills

Root Cause Analysis

Project Management

Quality Monitoring

Statistical Techniques

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Job description

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.

Qualifications

• 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.