Quality Assurance Engineer Job Summary
This role involves overseeing key elements of the Quality Management System, Batch Release, and ensuring compliance to applicable standards across all levels of the organization. As a Quality Assurance Engineer, you will be responsible for managing the Customer Complaint handling through to resolution, performing post-market surveillance planning and reporting, and providing expert guidance and knowledge to technical and validation teams.
The ideal candidate will have extensive experience within a QA role within a medical device or pharmaceutical industry (experience with ISO 13485 required), a degree in a scientific field or equivalent qualifications, and strong problem-solving ability. Additionally, you should be able to manage multiple stakeholder groups from operators to executive management.