Quality Compliance Engineer

📋 Description

• Provide design control and risk management expertise to medical device and combination product
• Generate and review design history file and risk management file components
• Interact with cross functional development teams at all levels of the client's organisation
• Implement effective continuous improvement initiatives
• Support regulatory submissions, audit readiness and compliance activities
• Perform complex data analysis to support informed decision-making

🎯 Requirements

• Degree in scientific, engineering or life sciences discipline (BSc, MSc or PhD)
• Strong knowledge of design controls, risk management, combination products and applicable
• Proven experience in regulated GxP environments, with understanding of ISO 13485, ISO 14971, 21 CFR
• Demonstrable expertise in design controls, risk management and combination product development
• Knowledge of human factors engineering, usability engineering, device assembly and manufacturing
• Excellent analytical, problem-solving and data evaluation skills

🎁 Benefits

• Being part of a Reward and Recognition Scheme
• Holiday entitlement increases with service
• Option to opt into Health Cash Plan
• Life Assurance from day one (four times annual salary)
• Automatic enrolment into Company Pension Plan after three months
• Access to Employee Assistance Programme (24/7 confidential support)