Quality Compliance Specialist

About the role

The Quality Compliance Specialist will drive the Corrective and Preventive Action (CAPA) process from issue identification through to closure, ensuring robust execution and high-quality documentation. You will work closely with cross-functional teams to maintain regulatory compliance and promote a strong quality culture.

Key responsibilities

• Support CAPA investigations, including issue identification, root cause analysis (5 Whys, Ishikawa, statistical analysis), corrective actions, effectiveness checks and closure in line with regulatory and QMS requirements.
• Partner with Quality, Engineering, Manufacturing, Service and Commercial teams to ensure timely execution of CAPA actions and sustained compliance.
• Monitor and analyse quality data to identify risks, trends and emerging non-conformances, enabling proactive interventions.
• Strengthen the compliance culture by delivering training and knowledge sharing on QMS, CAPA, regulatory expectations and best practices.

Required profile

• Minimum 2 years experience in FDA-regulated manufacturing or quality environments, focusing on CAPA investigations and process improvement.
• Understanding of end-to-end CAPA process and global medical device regulations (21 CFR Parts 803, 806, 820; ISO 13485; EUMDR; ISO 9001).
• Ability to analyse quality data to spot risks and trends.
• Vocational education or Bachelor’s degree in Engineering, Science or equivalent.
• Advanced written and verbal English communication skills.

Required skills

• CAPA investigation and management.
• Root cause analysis techniques (5 Whys, Ishikawa, statistical analysis).
• Quality data analysis.
• Regulatory compliance knowledge (21 CFR 803/806/820, ISO 13485, EUMDR, ISO 9001).