Medical Device Quality Engineer

This a Full Remote job, the offer is available from: Europe, European Union Our mission is to hasten the transition to universally accessible healthcare. We are authorised by governments to assess and grant market access to medical AIs. Our groundbreaking approach enables the most innovative technology to reach patients safely and quickly. Scarlet is the pre-eminent authority on AI medical devices. We serve customers that matter. Companies building bleeding-edge medical AI systems choose Scarlet. We are proud to count the world’s best resourced and most ambitious companies building medical AI as customers. You will be joining a team with product-market fit, flowing data, and exponentially growing revenue. Come help us bring the next generation of healthcare to the people who need it. About this role: Scarlet’s Quality Team plays a pivotal role in ensuring that Medical Device Manufacturers meet and exceed the Quality Management System (QMS) requirements laid out by the regulators. With deep expertise in regulatory standards, the team designs efficient workflows that enable timely and secure QMS audits of the next generation of Healthtech products. The Quality Team's goal is to ensure full compliance and operational excellence—both within Scarlet and for Medical Device Manufacturers. Your responsibilities:

• Get authorised to audit and certify the quality management systems of the most innovative healthcare companies in the world
• Decompose, interpret and implement relevant quality requirements (ISO 13485, ISO 17021, EU MDR, ISO 42001, ISO 27001, etc.)
• Optimise the assessment of customer data by designing efficient audit processes
• Be involved in maintaining and expanding Scarlet’s approvals in various jurisdictions and technologies

The key skills:

• Education - Bachelor’s degree in engineering, software engineering, computer science, physics or equivalent
• Work experience - Minimum of four years of professional experience in the field of medical devices
• Work experience - Minimum of two years of professional experience in quality management (e.g. ISO 13485, EU MDR, ISO 14971, etc.)
• Work experience - Experience auditing against medical device quality management requirements (e.g. ISO 13485, EU MDR, ISO 14971, etc.)
• Technical experience - Minimum one year of practical experience working with medical device software, demonstrating knowledge of relevant requirements (e.g. IEC 62304, IEC 82304, etc.), software development methodologies, cyber security etc.

Desirable skills:

• Work experience - Experience working with ISO 27001
• Analytical reader - You feel comfortable with reading normative texts and analysing and interpreting requirements to extract the essential information
• Ferociously curious - You like going down rabbit holes, understanding deeply how things work, and challenging the status quo
• Highly adaptable - You have worked in different environments and like operating with autonomy on sometimes ambiguous tasks

The Interview Process At Scarlet, we have built our interview processes to ensure you get to fully understand the role and Scarlet’s culture, and to ensure we get to know about your skills, expertise, and who you are. Here is what to expect:

• Recruiter Screen and Intro call with Hiring Manager - 45 mins
• Regulatory and Auditor Skills Interview with Quality Team - 45 mins
• Cross-functional Problem Solving Interview with Operations Team - 45 mins
• Founder Interviews - 2x30 mins
• References
• Offer

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