What are the responsibilities and job description for the Quality Engineer position at Katalyst HealthCares and Life Sciences?
Responsibilities :
- Prioritize timely completion and remediation of Corrective Action and Preventive Action (CAPA) - performing investigations, corrections, corrective actions, preventive actions and effectiveness checks.
- Perform review and remediation of Nonconforming Records and Product Holds
- Maintain, monitor and report trend analysis information on assigned products.
- Develop and maintain a robust process for identifying and monitoring root cause failure modes, frequency, and severity.
- Maintain and remediation process failure mode effects analysis (pFMEAs) for the products.
- Support returned product analysis and failure investigation activities for manufactured products (explant lab).
- Conduct all engineering activities in compliance with FDA's Quality System Regulation, Medical Device Directive (MDD), ISO 13485, Canadian CMDR, and other quality and regulatory requirements and standards.
- Demonstrate high level engineering thought processes that are based on both driving business objectives and product quality improvements.
- Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
Requirements :
Key Required Experience :
