Quality Director – Medical Devices & Plastic Injection Molding

About the role

We are seeking an experienced Quality Director to lead the Quality Management System for a leading international medical device manufacturer operating in Portugal and the United Kingdom. The role focuses on high‑precision plastic injection‑molded components for global healthcare customers.

Key responsibilities

• Lead and continuously improve the Quality Management System in compliance with ISO 13485, FDA and EU MDR requirements.
• Drive quality excellence across multiple manufacturing sites in Portugal and the UK.
• Lead customer audits, regulatory inspections and quality business reviews.
• Support New Product Introduction, validation activities and product launch programmes.
• Develop and mentor Quality teams while fostering a culture of continuous improvement and operational excellence.
• Act as the primary quality interface for strategic global customers.

Required profile

• Bachelor’s degree in Engineering, Quality, Life Sciences or a related technical field.
• 10+ years of progressive leadership experience in Medical Device Manufacturing Quality.
• Strong background in Plastic Injection Molding and regulated manufacturing environments.
• Proven experience with ISO 13485, FDA regulations, customer audits and quality system management.
• Experience managing multi‑site Quality organisations.
• Excellent leadership, communication and stakeholder management skills.
• Fluent English and availability to travel regularly between Portugal and the United Kingdom.

Required skills

• ISO 13485
• FDA regulations
• EU MDR
• Plastic injection molding
• Quality management systems

What we offer

• Strategic leadership position within a growing international organisation.
• Opportunity to shape and drive Quality strategy across multiple manufacturing sites.
• Exposure to leading global medical device customers.
• Dynamic environment focused on innovation, operational excellence and continuous improvement.