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: Competitive salary, flexible work options, and opportunities for professional growth.
- Other info: Dynamic work environment with a focus on innovation and collaboration.
- Why this job: Make a real impact in the healthcare sector while ensuring quality and compliance.
- Qualifications: Bachelor's degree in engineering or related field and experience in medical device quality management.
The predicted salary is between 46000 - 52000 £ per year.
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
Medical Device Quality Engineer in London employer: PassFort
At Scarlet, we are committed to fostering a dynamic and inclusive work environment where innovation thrives. As a Medical Device Quality Engineer, you will play a crucial role in shaping the future of healthcare while enjoying comprehensive benefits, professional development opportunities, and a culture that values curiosity and adaptability. 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 rapidly evolving healthtech landscape.
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 folks in the medical device industry on LinkedIn or at local meetups. We all know that sometimes it’s not just what you know, but who you know that can help you land that Quality Engineer role.
✨Tip Number 2
Prepare for those interviews! Research Scarlet and understand our mission to make healthcare accessible. We want to see your passion for quality management and how you can contribute to our goals during the interview process.
✨Tip Number 3
Show off your skills! Bring examples of your past work with ISO standards and quality management systems to the table. We love seeing how you’ve tackled challenges in your previous roles and how you can apply that experience here.
✨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 us you’re genuinely interested in being part of our mission to revolutionise 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 innovation and how your skills can help us ensure compliance and operational excellence. Keep it concise but impactful—show us your enthusiasm for the role!
Showcase Your Technical Skills:Don’t forget to highlight your technical experience, especially with medical device software and programming languages. We’re looking for someone who understands the nitty-gritty of quality management systems, so make sure to mention any relevant projects or tools you’ve used.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It helps us keep everything organised and ensures your application gets the attention it deserves. Plus, it’s super easy—just follow the prompts and let us know why you’d be a great fit!
How to prepare for a job interview at PassFort
✨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 Analytical Skills
Prepare to demonstrate your ability to interpret complex regulatory texts. Bring examples of how you've successfully decomposed and implemented quality requirements in past projects, as this will highlight your analytical prowess.
✨Be Ready for Problem Solving
Expect to tackle cross-functional problems during the interview. Brush up on your problem-solving techniques and think of scenarios where you’ve had to adapt quickly to ambiguous situations, showcasing your adaptability and curiosity.
✨Engage with the Culture
Research Scarlet’s mission and values thoroughly. During the interviews, express how your personal values align with theirs, and be prepared to discuss how you can contribute to their goal of making healthcare universally accessible.
