At a Glance
- Tasks: Support global quality projects and ensure product excellence in a regulated environment.
- Company: Leading medical device organisation focused on improving patient outcomes.
- Benefits: Competitive salary, career growth, and the chance to make a real impact.
- Other info: Fast-paced environment with opportunities for professional development.
- Why this job: Join a team driving quality initiatives that enhance healthcare worldwide.
- Qualifications: Degree in engineering or science with experience in quality management systems.
The predicted salary is between 40000 - 55000 £ per year.
We are seeking an experienced External Quality Engineer to join our Quality Assurance – Compliance team. This role is critical in supporting cross-site quality activities, manufacturing transfers, and OEM partnerships within a highly regulated medical device environment.
Key Responsibilities
- Support cross-site quality projects across multiple global locations
- Provide quality engineering input into manufacturing transfers and OEM activities
- Collaborate with internal and external stakeholders to ensure consistent product quality
- Support business and inspection meetings, contributing to quality performance and improvement
- Drive process improvements and change management activities across sites
- Ensure all activities comply with applicable regulatory standards and internal procedures
Requirements
- Degree qualified (or equivalent) in an engineering or scientific discipline
- Experience working within a Quality Management System in a medical device or regulated environment
- Strong knowledge of regulatory standards including ISO 13485, EU MDR, and FDA 21 CFR Part 820
- Excellent problem-solving, analytical, and organisational skills
- Strong communication skills with the ability to work across multiple sites and functions
- Ability to manage workload effectively in a fast-paced environment
Why Join Us?
This is an excellent opportunity to contribute to global quality initiatives within a leading medical device organisation, supporting innovative products that improve patient outcomes worldwide.
External Quality Engineer in Erskine employer: Terumo Aortic
Join our dynamic team as an External Quality Engineer and be part of a leading medical device organisation that prioritises innovation and quality. We offer a collaborative work culture that fosters professional growth, with opportunities to engage in cross-site projects and contribute to global quality initiatives. Located in a highly regulated environment, we provide comprehensive training and support to ensure your success while making a meaningful impact on patient outcomes worldwide.
