Systems Engineer

About the role

Lead and maintain the effectiveness of the Corrective and Preventive Action (CAPA) system. Ensure ongoing compliance with applicable global regulatory requirements and quality standards. Drive continuous improvement, robust root cause analysis, and audit readiness. Act as a subject matter expert for CAPA, non-conforming product, deviations, and compliance activities.

Lead end-to-end CAPA processes including initiation, investigation, action planning, and effectiveness verification. Monitor CAPA metrics and quality data trends to identify systemic issues and drive continuous improvement.

Responsibilities

• Lead and maintain the CAPA system to ensure effectiveness and compliance with global regulatory requirements and quality standards.
• Drive continuous improvement and robust root cause analysis.
• Serve as a subject matter expert for CAPA, non-conforming product, deviations, and compliance activities.
• Manage end-to-end CAPA processes: initiation, investigation, action planning, and effectiveness verification.
• Monitor CAPA metrics and quality data trends to identify systemic issues.
• Review and approve CAPA records for completeness, accuracy, and timeliness.
• Facilitate cross-functional CAPA review meetings.

Requirements

• Experience with CAPA management within a regulated industry (e.g., medical devices).
• Knowledge of applicable regulations (e.g., FDA 21 CFR Part 820, ISO 13485, EU MDR).
• Strong skills in root cause analysis (e.g., 5 Whys, Fishbone, Fault Tree Analysis).
• Excellent communication and interpersonal skills.

Benefits

• An environment that fosters independence and innovation.
• Opportunity to contribute to groundbreaking solutions in medical devices.
• Impact on healthcare challenges and lives globally.