Medical Device QMS Auditor — ISO 13485, MDR | Equity

United States Digital Space LLC

Greater London

On-site

GBP 75,000 - 90,000

Full time

14 days+

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Benefits offered by this job

Equity

Job summary

United States Digital Space LLC is seeking a Medical Device Auditor to audit manufacturers’ quality management systems against ISO 13485, EU MDR and UK MDR. You will learn our audit methods and deliver clear conclusions to support certification decisions.

The role involves reviewing records, interviewing teams, documenting evidence and communicating findings, with limited travel. You help bring safe devices to patients faster while upholding rigorous regulatory standards.

Qualifications

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.

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.