Systems Engineer
Haystack · Atlanta, GA · 6 days ago
HybridFull-time
About the role
The Role Lead is responsible for maintaining the effectiveness of the Corrective and Preventive Action (CAPA) system.
Responsibilities
- Ensure ongoing compliance with applicable global regulatory requirements and quality standards.
- Drive continuous improvement and ensure robust root cause analysis.
- Lead end-to-end CAPA, non-conforming product, and deviation processes.
- Monitor CAPA metrics and quality data source trends to identify systemic issues.
- Facilitate cross-functional CAPA review meetings and provide guidance on investigation techniques.
Requirements
- Subject matter expertise for CAPA, non-conforming product, deviations, and compliance activities.
- Experience ensuring CAPA activities comply with regulations (e.g., FDA 21 CFR Part 820, ISO 13485, EU MDR).
- Ability to review and approve CAPA records for completeness, accuracy, and timeliness.
- Proficiency in implementing and promoting best practices in root cause analysis (e.g., 5 Whys, Fishbone, Fault Tree Analysis).
- Skill in analyzing quality data and trends to proactively identify risks and opportunities.
- Strong communication and organizational skills.