Change Control Specialist

We are currently recruiting for a Change Control Specialist to join our Quality Assurance team. This role plays a critical part in ensuring the effective management and documentation of change control processes within a highly regulated medical device environment.

You will work collaboratively across multiple functions, supporting key quality processes and ensuring compliance with regulatory standards, company policies, and quality requirements.

Key Responsibilities

• Maintain and support the change control process and associated documentation
• Provide guidance and support to departments on developing and implementing change control plans
• Support Quality Engineering activities across R&D, Manufacturing, Engineering and Quality functions
• Prepare and maintain quality system documentation and records
• Generate trending data and reports for management, regulatory bodies and customers
• Drive continuous improvement of change control processes
• Ensure compliance with Quality Management Systems and maintain audit readiness at all times
  
  

About You

You will have a strong background in Quality Assurance within a regulated environment, ideally within the medical device sector.

• Degree in Science or Engineering (or equivalent experience)
• Experience working within a Quality Management System in a regulated industry
• Strong understanding of regulatory standards and QMS requirements
• Excellent analytical, organisational and problem-solving skills
• Strong communication and stakeholder management capability
• Ability to manage priorities and meet deadlines in a fast-paced environment
• Proficient with Microsoft Office and quality systems/tools
  
  

Why Join Us

At Terumo Aortic, you’ll be part of a collaborative and innovative organisation committed to improving patient outcomes worldwide. You will have the opportunity to work across global teams, contribute to meaningful change, and grow your career within a regulated and high-impact environment.