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
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• 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

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

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.

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