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.