What you will do-

This position plays a critical role in ensuring that products meet the highest quality and regulatory standards. The individual will be responsible for defining and maintaining quality processes, overseeing compliance with FDA and ISO requirements, and leading a team of quality professionals to ensure that operations, suppliers, and products align with company standards and external regulations.

Key Responsibilities:

• Ensure full compliance with FDA, ISO13485, and other applicable regulatory and quality standards across operations and suppliers.
• Define, approve, and implement inspection, testing, and evaluation procedures to maintain product accuracy, precision, and reliability.
• Lead and participate in internal and external audits, including preparing documentation, managing corrective actions, and communicating results.
• Oversee complaint management, failure analysis, and nonconformance investigations, ensuring proper documentation and corrective actions.
• Supervise, coach, and develop a team of Quality Engineers, Technicians, Supervisors, and Coordinators, setting departmental goals and monitoring performance.
• Provide training on Quality Assurance and Regulatory Affairs topics to ensure organizational knowledge and compliance.
• Maintain and review product controls, acceptance activities, and environmental health and safety management practices to drive continuous improvement.
• Generate, review, and communicate detailed proposals, guidelines, and procedures to support decision-making across departments.

What you need-

Required:

• B.S. in engineering, engineering management, or related discipline.
• Advanced English skills.
• Minimum of 3 years in Quality Assurance or related functional area.
• Minimum of 2 years as a supervisor of QA/RA function or equivalent experience.
• Minimum of 1 year of experience as people manager.
• Previous experience in the regulated manufacturing sector.

Desired:

• ISO Lead Auditor training; Certified Quality Engineer (ASQ).
• Previous Experience in the Medical Devices sector.