Quality Assurance Specialist

Key Responsibilities

• Maintain and update Risk Management Files in line with ISO 14971 requirements
• Perform risk assessments, hazard analyses, and benefit-risk evaluations for new and existing products
• Assess complaints, CAPAs, PMS data, and design changes for potential risk impact
• Support MDR technical documentation and regulatory submissions
• Work closely with Quality, Regulatory Affairs, R&D, Clinical and Manufacturing teams
• Support responses to Notified Body questions relating to risk management activities
• Drive continuous improvement of risk management processes, documentation and methodologies
• Provide risk management guidance to internal stakeholders throughout the product lifecycle

Requirements

• 5+ years' experience within the medical device industry
• Strong hands-on experience with ISO 14971 and medical device risk management
• Good understanding of EU MDR and technical documentation requirements
• Experience supporting Class IIa, IIb or Class III medical devices
• Comfortable working independently and engaging with cross-functional teams