Quality & Clinical Validation Lead

The Quality Assurance & Clinical Validation Lead will be responsible for establishing and maintaining the Quality Management System (QMS) in compliance with ISO 13485, while simultaneously planning and executing clinical and design validation activities to demonstrate that medical devices meet intended use, user needs, and clinical performance requirements. This role acts as a critical bridge between R&D, Clinical, Regulatory, and Manufacturing, ensuring that product development is compliant with regulatory requirements and industry standards. The Quality & Clinical Validation Lead will be responsible for developing and implementing quality procedures, conducting audits and assessments to ensure compliance with QMS, and providing training and support to employees on quality-related matters. Additionally, this role will involve planning and executing clinical trials, designing validation protocols, and analyzing data to demonstrate the safety and efficacy of medical devices. The Quality & Clinical Validation Lead must have a strong understanding of regulatory requirements, industry standards, and quality management principles.