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.
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