CAPA Quality Engineer

Job Title: CAPA Quality Engineer
Location: Hybrid Murrysville, PA or Cambridge, MA

11 Months

Job Responsibilities

• Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solutions and effectiveness monitoring.
• Project manage all aspects of CAPA activities, including coordination of cross-functional resources, scheduling CAPA meetings, and ensuring deliverables are completed within project timelines.
• Represent CAPAs during audits and CAPA Review Board meetings.
• Lead and mentor cross-functional teams in the implementation of appropriate root cause analysis techniques (e.g., Pride problem solving).
• Analyze quality monitoring data 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 are supported with appropriate resources and implementation plans.
• Independently create and complete CAPA records.
• Perform detailed CAPA engineering tasks including assessing issue descriptions, reviewing CAPA data sources, supporting root cause analysis, and quality problem-solving activities.
• Lead CAPA engineering activities including complex investigations, corrective actions, review of testing/performance data, root cause analysis, and quality issue resolution.

Required Skills & Experience

• Strong understanding of software and hardware quality/design issues.
• Demonstrated experience with root cause analysis methodologies and investigation techniques.
• Strong knowledge of global quality regulations and standards including:
• 21 CFR Parts 803, 806, and 820
• ISO 13485
• ISO 9001
• ISO 14971
• Strong project management skills with the ability to manage multiple CAPA activities.
• Ability to analyze data and apply statistical techniques.
• Strong written and verbal communication skills.
• Ability to work effectively across all organizational levels and influence stakeholders.

Education Requirements

• Bachelor s degree in Engineering with 5+ years of related experience
  OR
• Master s degree with 3+ years of related experience.

Position Details

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