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:

• Engineering degree or BS/MS (i.e. mechanical, electro-mechanical, electrical, etc.) or equivalent experience.
• 7+ years of experience in medical device quality, preferably in remediation.
• Working knowledge of FDA QSRs, 13485 and 14971.
• Ability to manage multiple stakeholders and competing priorities.

Key Required Experience:

• 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