At a Glance
- Tasks: Manage and document change control processes in a regulated medical device environment.
- Company: Join Terumo Aortic, a leader in improving patient outcomes globally.
- Benefits: Collaborative culture, career growth opportunities, and impactful work.
- Other info: Fast-paced environment with a focus on continuous improvement and compliance.
- Why this job: Make a difference in healthcare while developing your skills in a dynamic team.
- Qualifications: Degree in Science or Engineering and experience in Quality Assurance.
The predicted salary is between 40000 - 50000 £ per year.
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.
Change Control Specialist in Renfrew employer: Terumo Aortic
At Terumo Aortic, we pride ourselves on fostering a collaborative and innovative work culture that prioritises employee growth and development. As a Change Control Specialist, you will be integral to our mission of improving patient outcomes, with access to global teams and opportunities for continuous improvement in a highly regulated medical device environment. Join us to make a meaningful impact while enjoying a supportive atmosphere that values compliance and quality excellence.
