Quality Engineer

A stable and highly successful medical device company with advanced, cutting-edge developments is seeking a Quality Engineer to join its team.

This is a key role with impact across the entire product lifecycle, ensuring compliance, safety, and product excellence from development through manufacturing.

Key Responsibilities:

• Lead CAPA processes, including investigation of quality issues, customer complaints, and non-conformities
• Perform root cause analysis and drive effective corrective and preventive actions
• Monitor implementation and verify effectiveness and timely closure of CAPAs
• Ensure compliance with quality management systems and regulatory requirements
• Participate in design reviews and support quality activities throughout the product lifecycle
• Collaborate closely with cross-functional teams including R&D, Manufacturing, and Regulatory

Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or a related field (Master’s degree – advantage)
• At least 2 years of experience in Quality Engineering, preferably within the medical device industry
• Strong knowledge of quality standards and regulatory frameworks (ISO 13485, CE, FDA)
• Experience with risk analysis, root cause investigations, and CAPA management
• Understanding of manufacturing processes, quality control methodologies, and statistical tools
• Strong analytical and problem-solving skills
• Ability to manage multiple priorities in a structured and organized manner
• Excellent written and verbal communication skills