Quality Auditor

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Plan and perform QMS audits in accordance with ISO 13485, EU MDR, and UK MDR standards.

• Evaluate documentation and engage with teams to determine if their processes comply with the necessary requirements.

• Compile evidence, findings, and conclusions into concise and timely audit reports.

• Communicate findings constructively and keep clients updated throughout the audit process.

• Review corrective actions and the necessary evidence to resolve audit findings.

• Evaluate quality management systems of medical device manufacturers and provide clear conclusions to support certification decisions.

• Assist in the timely delivery of safe medical devices to patients.

⛳️ Requirements

• A degree in a pertinent scientific, engineering, or medical field.

• A minimum of four years of experience in the medical device sector, including two years in auditing or managing an ISO 13485 QMS.

• Proficient understanding of EU MDR or UK MDR requirements for quality management systems.

• Ability to clearly articulate audit findings or regulatory requirements both in writing and verbally.

• Familiarity with software that demonstrates knowledge of software design, validation, testing, debugging, and interactions with its operating environment.

• Experience in conducting audits for a certification or notified body is preferred.

• Familiarity with medical device software is preferred.

🏝️ Benefits

• Equity

• Training in Scarlet’s auditing methods and tools

• Limited travel, with only occasional trips potentially required