Medical Device Auditor
Core
Audit medical device manufacturers' quality management systems to support certification decisions for AI-enabled medical devices.
Role type
Senior Medical Device Auditor (Quality Management Systems)
Builds
Certification infrastructure for medical device manufacturers
Domain
Medical Devices / Regulatory Compliance / Quality Management
Deliverable
client delivery
Required skills
ISO 13485 auditing, EU MDR/UK MDR requirements, QMS assessment, regulatory writing, software validation knowledge
Preferred skills
Notified body audit experience, medical device software auditing
Responsibilities
Plan and conduct QMS audits against ISO 13485, EU MDR and UK MDR; Review records and interview teams to assess process compliance; Document evidence, findings and conclusions in audit reports; Explain findings constructively to customers; Review corrective actions and evidence for closing findings
