scarlet - Medical Device Auditor

Remote - London, Greater London, United Kingdom£75k - £90k3w ago

Remote EMEA Medical Devices Auditor Smart Contract Auditor Reporting Close

Requirements

• A degree in a relevant scientific, engineering or medical discipline. • At least four years’ experience in the medical device industry, including two years auditing or managing an ISO 13485 QMS. • Working knowledge of EU MDR or UK MDR requirements for quality management systems. • Experience explaining audit findings or regulatory requirements clearly, in writing and in conversation. • Experience with software demonstrating knowledge of software design, validation, testing, debugging and interactions with its operating environment. • Experience conducting audits for a certification or notified body. • Experience with medical device software.

Responsibilities

• Plan and conduct QMS audits against ISO 13485, EU MDR and UK MDR requirements. • Review records and interview teams to assess whether their processes meet the requirements. • Document evidence, findings and conclusions in clear, timely audit reports. • Explain findings constructively and keep customers informed throughout the audit. • Review corrective actions and the evidence needed to close findings.

Benefits

• £75K – £90K • Offers Equity • Upload your resume here to autofill key application fields. • Drop your resume here! • Parsing your resume. Autofilling key fields... • or drag and drop here • Where are you currently based?