CAPA Quality Engineer

Job Title:

CAPA Quality Engineer Location:

Hybrid - Murrysville, PA 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. RAM#

Pay:

$60.00 - $85.00 per hour

Experience:

Medical Device:

2 years (Preferred)

CAPA:

6 years (Preferred) software and hardware quality/design : 4 years (Preferred) Root cause analysis: 4 years (Preferred) 21 CFR / ISO 13485 : 4 years (Preferred)

Work Location:

Hybrid remote in Murrysville, PA 15668