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 healthcare by ensuring the highest quality standards.
- Qualifications: Bachelor’s degree in engineering or related field; experience in medical devices and quality management.
The predicted salary is between 45000 - 55000 £ 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 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, supported by a culture that prioritises professional growth and collaboration. With access to cutting-edge technology and a focus on continuous learning, our employees enjoy unique opportunities to advance their careers while making a meaningful impact on global health.
StudySmarter Expert Advice🤫
We think this is how you could land Medical Device Quality Engineer
✨Tip Number 1
Get to know the company inside out! Research Scarlet's mission and values, especially how they relate to healthcare innovation. This will help you tailor your conversations during interviews and show that you're genuinely interested in being part of their team.
✨Tip Number 2
Practice makes perfect! Prepare for the interview by going through common questions related to quality management and medical devices. We recommend doing mock interviews with friends or using online platforms to boost your confidence.
✨Tip Number 3
Showcase your curiosity! During the interview, don’t hesitate to ask insightful questions about the role and the challenges the Quality Team faces. This demonstrates your eagerness to learn and adapt, which is key in a fast-paced environment like healthcare tech.
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re proactive and serious about joining Scarlet. Don’t miss out on this opportunity to be part of something impactful!
We think you need these skills to ace Medical Device Quality Engineer
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 achieve our mission. Be genuine and let your personality come through—this is your opportunity to connect with us.
Showcase Your Technical Skills:Don’t forget to highlight your technical expertise, especially if you have experience with medical device software or programming languages. We’re looking for someone who can dive deep into the technical requirements, so make sure we see that in your application!
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 us you’re serious about joining our team at Scarlet!
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 Problem-Solving Skills
During the cross-functional problem-solving interview, be prepared to demonstrate your analytical thinking. Think of specific examples where you’ve tackled complex issues in quality management or medical device software, and explain your thought process clearly.
✨Be Curious and Engaged
Scarlet values curiosity, so don’t hesitate to ask insightful questions about their processes and challenges. This not only shows your interest but also gives you a chance to demonstrate your knowledge and eagerness to learn more about the role.
✨Prepare for Technical Questions
Expect technical questions related to medical device software and quality management. Brush up on relevant programming languages and methodologies, and be ready to discuss how you’ve ensured compliance in past projects.
