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- Tasks: Audit and certify quality management systems for innovative healthcare companies.
- Company: Join Scarlet, a leader in AI medical devices transforming healthcare access.
- Benefits: Competitive salary, flexible work options, and opportunities for professional growth.
- Why this job: Be part of a mission to revolutionise healthcare with cutting-edge technology.
- Qualifications: Bachelor's degree in engineering or related field; experience in medical devices and quality management.
- Other info: Dynamic team environment with a focus on compliance and operational excellence.
The predicted salary is between 36000 - 60000 £ per year.
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
Medical Device Quality Engineer in London employer: The Scarlet Company Group
Contact Detail:
The Scarlet Company Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Medical Device Quality Engineer in London
✨Tip Number 1
Network like a pro! Reach out to people in the medical device industry, especially those who work at companies you're interested in. A friendly chat can open doors and give you insider info that could help you stand out.
✨Tip Number 2
Prepare for your interviews by diving deep into the company’s mission and values. At Scarlet, we’re all about making healthcare accessible, so show us how your passion aligns with our goals during the interview!
✨Tip Number 3
Practice makes perfect! Mock interviews can help you get comfortable with common questions and improve your confidence. Don’t forget to highlight your experience with quality management systems and regulatory standards!
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in joining our team at Scarlet and contributing to the future of healthcare.
We think you need these skills to ace Medical Device Quality Engineer in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Medical Device Quality Engineer role. Highlight your relevant experience in quality management and any specific standards you've worked with, like ISO 13485 or EU MDR. We want to see how your background aligns with our mission!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about healthcare and how your skills can help us at Scarlet. Be sure to mention any innovative projects you've been part of that relate to medical devices.
Showcase Your Curiosity: We love ferociously curious candidates! In your application, share examples of how you've gone above and beyond to understand complex regulations or improve processes. This will show us that you’re not just ticking boxes but genuinely interested in the field.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to keep track of your application and ensure it gets the attention it deserves. Plus, it shows you’re serious about joining our team at Scarlet!
How to prepare for a job interview at The Scarlet Company Group
✨Know Your Standards
Make sure you’re well-versed in the relevant quality management standards like ISO 13485 and EU MDR. Brush up on how these apply to medical devices, as you’ll likely be asked to discuss your experience with them during the interview.
✨Showcase Your Curiosity
Scarlet values a ferociously curious mindset. Be prepared to share examples of how you've gone above and beyond to understand complex systems or processes. This could involve discussing a time you tackled a challenging problem or dove deep into a regulatory requirement.
✨Prepare for Cross-Functional Questions
Since you'll be working with various teams, think about how you can demonstrate your ability to collaborate across functions. Prepare examples that highlight your problem-solving skills and adaptability in different environments.
✨Engage with the Culture
Familiarise yourself with Scarlet’s mission and values. During the interview, express your enthusiasm for their goal of making healthcare universally accessible. Showing that you align with their culture can set you apart from other candidates.