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- Tasks: Lead the Quality Management System and ensure compliance with global regulations.
- Company: Exciting Medtech start-up focused on innovation and patient safety.
- Benefits: Remote work, competitive salary, and a chance to shape quality strategy.
- Why this job: Make a real impact in the medical device industry and ensure patient safety.
- Qualifications: 8+ years in Quality/Compliance with strong leadership skills.
- Other info: Opportunity for career growth and travel for audits and inspections.
The predicted salary is between 36000 - 60000 ÂŁ per year.
An innovative MedTech startup in London looking for a Senior Quality Engineer to help build and lead their Quality Management System (ISO 13485) and support the development of their first implantable medical device.
You’ll work closely with the design teams to ensure products are developed in a controlled, compliant, and scalable way contributing directly to the company’s mission to transform neurological care through cutting‑edge silicon‑based technology.
What you’ll be doing :
- Own and maintain QMS processes in line with ISO 13485
- Lead QMS remediation and eQMS implementation projects
- Support design and development (DHF, FMEA, design reviews)
- Oversee supplier qualification, goods handling, and documentation compliance
- Champion quality culture across engineering and operations
What you’ll need :
- 4+ years’ experience in Quality Engineering within medical devices
- Deep knowledge of ISO 13485 and design controls
- Essential: experience working with integrated circuits or silicon‑based technologies
- Strong documentation, organisational, and process‑driven mindset
- Hands‑on approach and comfort in a complex engineering environment
If you’re a MedTech QA professional who thrives in a hands‑on, fast‑paced setting — and want to help bring life‑changing technology to market please apply to the advert or get in touch for more details
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Senior Quality Assurance Engineer employer: GxPeople Global
Contact Detail:
GxPeople Global Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Assurance Engineer
✨Tip Number 1
Network like a pro! Reach out to your connections in the Medtech industry and let them know you're on the lookout for opportunities. Sometimes, a friendly chat can lead to a hidden job opening that’s not even advertised.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO 13485 and other relevant regulations. We want you to be able to discuss how you've implemented quality management systems in the past, so have some solid examples ready to share.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and expertise. When you find a role that excites you, apply through our website to ensure your application gets the attention it deserves!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. Plus, it shows your enthusiasm for the role and the company, which is always a bonus.
We think you need these skills to ace Senior Quality Assurance Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Quality Assurance Engineer role. Highlight your experience with ISO 13485 and any relevant projects you've led. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality systems in the medical device sector. Share specific examples of your achievements that relate to the job description.
Showcase Your Leadership Skills: Since this role involves leading audits and managing teams, make sure to highlight your leadership experience. We love seeing how you've driven continuous improvement initiatives or managed compliance in past roles.
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 this exciting opportunity. Don’t miss out!
How to prepare for a job interview at GxPeople Global
✨Know Your QMS Inside Out
Make sure you’re well-versed in ISO 13485 and the specifics of Quality Management Systems. Be ready to discuss how you've developed, implemented, or maintained a QMS in your previous roles. This will show that you can hit the ground running.
✨Showcase Your Leadership Skills
Prepare examples of how you've led audits, risk management initiatives, or CAPA processes. Highlight your experience in managing teams and driving continuous improvement. This is crucial for demonstrating your fit for a senior role.
✨Familiarise Yourself with Regulatory Requirements
Brush up on GMP, GDP, and MA requirements, as well as any recent changes in regulations. Being able to discuss these confidently will impress interviewers and show that you’re proactive about compliance.
✨Prepare for Scenario-Based Questions
Expect questions that ask how you would handle specific situations, like a regulatory inspection or a supplier audit. Think through your past experiences and be ready to explain your thought process and decision-making.
