Quality Assurance Specialist

QA Specialist/Officer – West Yorkshire – Medical Device About the Company: We are looking for an experienced quality professional from the medical device industry to join an established company in the Leeds area. As part of the compliance team, you will ensure adherence to GMP and ISO 13485 standards. Responsibilities: • Document control and change control. • NCR’s, deviations and customer complaint investigations. • QMS maintenance and management. • Root cause and CAPA. • Batch release. • External auditing support. • Validation (sterilisation, microbiology and environmental monitoring). • Trend analysis and reporting. • Updating, improving and compiling SOP’s. • Internal auditing. • Quality systems training. • Leading quality improvement projects. Requirements: • Previous experience working within a quality role at a medical device company. • Experience in NCR’s and CAPA. • A good understanding of ISO 13485. • Excellent attention to detail. • Excellent communication skills.