[Hiring] Quality Auditor @Scarlet

Role Description

As a Quality Auditor at Scarlet, you will audit medical device manufacturers’ quality management systems and produce clear conclusions that support certification decisions. You’ll receive training in Scarlet’s audit methods and tools. Your work will combine reviewing evidence with conversations about how manufacturers’ processes work in practice. Travel will be limited, though occasional trips may be required. You will help safe devices reach patients sooner.

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.

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.

Preferred Qualifications

• Experience conducting audits for a certification or notified body.
• Experience with medical device software.

Interview Process

• Introductory call with Sandy — 30 minutes.
• QMS audit exercise and discussion with Felicia — 60 minutes.
• Culture and values interviews with James and Jamie — 30 minutes each.
• References and offer.