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Manage the development and implementation of a comprehensive software design quality strategy aligned with Sibel Healths missions and goals, and regulatory requirements.

Provide governance for software design quality throughout the product development lifecycle, fostering a culture of quality, continuous improvement, and compliance.

Manage and oversee all aspects of design quality assurance activities, including design verification and validation, and risk management, in compliance with applicable regulatory standards such as ISO 13485, IEC 62304, and FDA 21 CFR Part 820.

Ensure robust design control processes are in place, including design reviews, design history files (DHF), and design transfer activities.

Guide cross-functional teams, including R&D, manufacturing, regulatory affairs, clinical, and product management, to ensure seamless integration of quality assurance processes for software development projects.

Develop and maintain quality metrics, key performance indicators (KPIs), and reporting systems to monitor and enhance product quality and reliability.

Ensure compliance with global regulatory requirements and standards for software development and design controls, as established by agencies, including but not limited to the FDA, EU Commission, TGA, Health Canada, and other relevant regulatory bodies.

Lead internal and external audits, inspections, and assessments, addressing any findings or non-conformances promptly and effectively.

Implement robust corrective and preventive action (CAPA) processes to address product quality issues and drive continuous improvement.

Sibel Health Inc.

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