Revolutionize the future of healthcare with our cutting-edge medical technology team.
At Scarlet, we're transforming medical devices into life-changing solutions that improve patient outcomes. By combining clinical, technical, and regulatory expertise with advanced AI agents and software, we ensure rigorous certification keeps pace with the rapid advancements in technology.
Our customers have dramatically shortened their certification timelines and accelerated product updates, often cutting years off the process and reducing product-update cycles from months to weeks. You'll be part of a team that is building the infrastructure that makes these remarkable outcomes repeatable at scale.
About the Role
As a Medical Device Auditor at Scarlet, you'll play a crucial role in the quality management system (QMS) audits of medical device manufacturers. Your responsibilities include:
- Develop and execute QMS audits in accordance with ISO 13485, EU MDR, and UK MDR requirements.
- Review evidence, interview teams, and document findings to support certification decisions.
- Provide clear explanations of findings and keep clients informed throughout the audit process.
- Review and close corrective actions with the evidence needed to close findings.
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.
Required Qualifications
- A degree in a relevant scientific, engineering, or medical discipline.
- Four years of experience in the medical device industry, including two years auditing or managing an ISO 13485 QMS.
- 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: A brief conversation with Sandy to discuss the job opportunity and set expectations.
- QMS Audit Exercise with Felicia — 60 minutes: A practical exercise where you will audit a QMS system and discuss your findings with Felicia.
- Culture and Values Interviews with James and Jamie — 30 minutes each: Conversations with James and Jamie to understand the company's culture and values.
- References and Offer — Provide references and secure an offer.
Compensation: £75K – £90K • Offers Equity
- • £75K – £90K • Offers Equity
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