At a Glance
- Tasks: Audit and certify quality management systems for innovative healthcare companies.
- Company: Join a mission-driven team transforming healthcare accessibility with cutting-edge technology.
- Benefits: Flexible remote work, competitive salary, and opportunities for professional growth.
- Other info: Dynamic work environment with a focus on innovation and compliance.
- Why this job: Make a real impact in the healthcare sector while working with advanced technologies.
- Qualifications: Bachelor’s degree in engineering or related field and experience in medical device quality management.
Our mission is to hasten the transition to universally accessible healthcare. We deliver on this mission by enabling innovators to bring cutting-edge software and AI to the healthcare market safely and quickly. We're regulated by the UK Government and European Commission to do so. Our certification process is optimised for software and AI, facilitating a more efficient time to market, and the frequent releases needed to build great software. This ensures patients safely get the most up-to-date versions of life-changing technology. 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, and one or more programming languages
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
Remote Medical Device Quality Engineer in Plymouth employer: Scarlet
At Scarlet, we are committed to fostering a dynamic and inclusive work environment that empowers our employees to thrive. As a Remote Medical Device Quality Engineer, you will play a crucial role in shaping the future of healthcare while enjoying flexible working arrangements, continuous professional development opportunities, and a culture that values innovation and collaboration. Join us in our mission to make healthcare accessible for all, and be part of a team that is dedicated to operational excellence and compliance in the ever-evolving healthtech landscape.
StudySmarter Expert Advice🤫
We think this is how you could land Remote Medical Device Quality Engineer in Plymouth
✨Tip Number 1
Network like a pro! Reach out to people in the medical device industry on LinkedIn or at events. A friendly chat can lead to opportunities that aren’t even advertised yet.
✨Tip Number 2
Prepare for your interviews by researching Scarlet’s mission and values. Show us how your skills align with our goal of making healthcare accessible. We love candidates who are genuinely passionate about what we do!
✨Tip Number 3
Practice your answers to common interview questions, especially around quality management systems and regulatory standards. We want to see your expertise shine, so be ready to share specific examples from your experience.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining our team.
We think you need these skills to ace Remote Medical Device Quality Engineer in Plymouth
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of a Medical Device Quality Engineer. Highlight your relevant experience in quality management and medical devices, and don’t forget to mention any specific standards you’ve worked with, like ISO 13485 or EU MDR.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about healthcare innovation and how your skills align with our mission at StudySmarter. Be genuine and let your personality come through!
Showcase Your Technical Skills:Don’t shy away from showcasing your technical expertise. Mention any programming languages you know and your experience with medical device software. This will help us see how you can contribute to our cutting-edge projects.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Scarlet
✨Know Your Standards
Familiarise yourself with the key quality management standards like ISO 13485 and EU MDR. Be ready to discuss how you've applied these in your previous roles, as this will show your expertise and understanding of the regulatory landscape.
✨Showcase Your Curiosity
Demonstrate your ferocious curiosity by preparing questions that dive deep into the company's processes and challenges. This not only shows your interest but also your analytical mindset, which is crucial for a Quality Engineer.
✨Prepare for Problem Solving
Since you'll face cross-functional problem-solving interviews, think of specific examples where you've tackled complex issues in quality management. Use the STAR method (Situation, Task, Action, Result) to structure your responses clearly.
✨Cultural Fit Matters
Scarlet values adaptability and autonomy, so be prepared to share experiences where you've thrived in ambiguous situations. Highlight how you can contribute to their mission of making healthcare accessible while fitting into their culture.
