What are the responsibilities and job description for the CAPA Quality Engineer position at ComTec Information Systems?
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.
Salary : $60 - $80