Site Quality Leader

About the role

The Quality Assurance Manager is appointed by Top Management as the Site Quality Management Representative, responsible for product quality, compliance with applicable standards, and fostering a culture of quality across the site. The role also drives operational objectives, KPI monitoring, and continuous improvement initiatives within the manufacturing environment.

Key responsibilities

• Lead product quality and compliance activities, reviewing and approving finished products and managing inspections.
• Establish operational objectives, delegate tasks, and monitor key performance indicators to ensure efficient execution.
• Develop, modify, and execute company policies impacting site operations and drive continuous improvement.
• Own audit and assessment processes, support internal and external audits, and close regulatory compliance gaps.
• Manage the quality assurance team, overseeing talent acquisition, performance, compensation, and career development.

Required profile

• Bachelor's or Master's degree in Quality Management, Engineering, Science or related field.
• Minimum 5 years of experience (or 3 years with a Master's) in medical device quality assurance, quality control, audit, compliance or related areas.

Required skills

• Quality Assurance (QA) and Quality Management Systems (QMS) expertise.
• CAPA methodologies and supplier quality management.
• Risk management and regulatory compliance knowledge.
• Proficiency with ISO 13485, ISO 9001 and ISO 14971 standards.
• KPI management and continuous improvement techniques.