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- Tasks: Lead quality initiatives and ensure compliance in medical device software development.
- Company: Join a pioneering HealthTech company transforming patient care with innovative solutions.
- Benefits: Enjoy a competitive, flexible remuneration package and the chance to work remotely.
- Why this job: Be at the forefront of AI-driven innovation in a fast-growing MedTech environment.
- Qualifications: Strong background in Medical Devices, EU MDR & FDA QSR regulations required.
- Other info: This role is perfect for those passionate about quality improvements in healthcare.
The predicted salary is between 43200 - 72000 £ per year.
Zest Scientific is partnering with a leading European HealthTech to identify a Senior QA Engineer. This is a unique opportunity to join a fast-growing MedTech business at the forefront of AI-driven innovation, enhancing diagnostic accuracy, advancing treatment pathways, and improving clinical outcomes.
As part of the Quality & Compliance team, you will play a pivotal role in shaping the quality strategy for cutting-edge medical device software and instrument development. You will ensure cross-functional collaboration across engineering, manufacturing, and operations, implementing robust QMS principles in a high-growth, innovation-driven environment.
The Candidate:
- Accomplished Quality professional with a strong track record in the Medical Devices sector, ensuring compliance with EU MDR & FDA QSR regulations.
- Expertise in ISO 13485, IEC 62304, IEC 62366, and ISO 14971.
- Experience in high-growth/start-up environments, ideally within an international, remote-first engineering team.
- Hands-on experience with data management, automation, and Agile methodologies.
- Passionate about driving quality improvements and championing change.
Location: Europe.
The Role:
- Lead quality and compliance initiatives, ensuring QMS validation and automation of software testing.
- Collaborate cross-functionally with engineering, manufacturing, and operations to integrate quality systems across business processes.
- Support medical device software and instrument development, ensuring best practices in quality management.
The Company:
- Innovative HealthTech / MedTech company, transforming patient pathways with evidence-based solutions.
- Rapidly scaling business, focused on early detection and preventative healthcare.
Remuneration & Application:
Our client is committed to attracting the right candidate and offers a competitive, flexible remuneration package. Zest Scientific is working to a strict deadline – apply now to be considered immediately.
Senior Quality Assurance Engineer employer: Zest Scientific Recruitment
Contact Detail:
Zest Scientific Recruitment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Assurance Engineer
✨Tip Number 1
Familiarise yourself with the latest trends in AI-driven healthcare technology. Understanding how these innovations impact quality assurance in medical devices will help you stand out during discussions.
✨Tip Number 2
Network with professionals in the MedTech industry, especially those who have experience with EU MDR and FDA QSR regulations. Engaging with them can provide insights and potentially lead to referrals.
✨Tip Number 3
Showcase your hands-on experience with Agile methodologies and automation tools in your conversations. Being able to discuss specific projects where you've implemented these practices can demonstrate your value.
✨Tip Number 4
Prepare to discuss how you've driven quality improvements in previous roles. Be ready with examples that highlight your ability to champion change and collaborate across teams, as this is crucial for the role.
We think you need these skills to ace Senior Quality Assurance Engineer
Some tips for your application 🫡
Understand the Role: Thoroughly read the job description for the Senior Quality Assurance Engineer position. Highlight key responsibilities and required skills, such as expertise in ISO standards and experience in the Medical Devices sector.
Tailor Your CV: Customise your CV to reflect your relevant experience in quality assurance, particularly in medical device software. Emphasise your accomplishments in compliance with EU MDR & FDA QSR regulations and any hands-on experience with Agile methodologies.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality improvements and your ability to drive change. Mention specific examples of how you've successfully implemented QMS principles in previous roles, especially in high-growth environments.
Highlight Cross-Functional Collaboration: In your application, emphasise your experience working collaboratively across engineering, manufacturing, and operations. Provide examples of how you have integrated quality systems into business processes to enhance overall performance.
How to prepare for a job interview at Zest Scientific Recruitment
✨Showcase Your Regulatory Knowledge
Make sure to highlight your understanding of EU MDR and FDA QSR regulations during the interview. Discuss specific experiences where you ensured compliance in previous roles, as this will demonstrate your expertise in the medical devices sector.
✨Emphasise Cross-Functional Collaboration
Since the role involves working closely with engineering, manufacturing, and operations, be prepared to share examples of how you've successfully collaborated with different teams. This will show that you can integrate quality systems across various business processes.
✨Demonstrate Your Passion for Quality Improvement
Express your enthusiasm for driving quality improvements and championing change. Share specific instances where you implemented successful quality initiatives or automated testing processes, as this aligns with the company's focus on innovation.
✨Prepare for Agile Methodology Questions
Given the emphasis on Agile methodologies, be ready to discuss your hands-on experience with Agile practices. Prepare to explain how you've applied these methodologies in past projects, particularly in high-growth or start-up environments.
