Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Ensure top-notch quality for innovative medical devices and support regulatory compliance.
- Company: Exciting MedTech company focused on advancing orthopaedic care.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Why this job: Make a real difference in patient outcomes while working with cutting-edge technology.
- Qualifications: Experience in QA within the medical device industry and knowledge of FDA regulations.
- Other info: Dynamic environment with a focus on continuous improvement and career advancement.
The predicted salary is between 36000 - 60000 £ per year.
We're working with an exciting MedTech company dedicated to advancing orthopaedic care through innovative medical device solutions. Their products improve patient outcomes and quality of life, and we're looking for a talented QA Engineer to help us maintain the highest standards of quality and regulatory compliance.
As a QA Engineer, you'll play a critical role in ensuring our orthopaedic products meet regulatory requirements and quality standards. You'll work closely with R&D, manufacturing, and regulatory teams to maintain our Quality Management System and support our growing portfolio of cutting-edge medical devices.
Key Responsibilities
- Support FDA and CE Mark regulatory submissions and ongoing compliance activities
- Maintain and improve our Quality Management System (QMS) in accordance with ISO 13485 and other relevant standards
- Prepare for and participate in internal and external audits, including FDA inspections and Notified Body assessments
- Review and approve quality documentation, including DHFs, DMRs, and technical files
- Investigate non-conformances and support CAPA processes
- Provide quality oversight for additive manufacturing processes, ensuring compliance with regulatory requirements
- Conduct supplier audits and manage vendor quality performance
- Support design control activities and product development projects
- Drive continuous improvement initiatives across the quality function
Essential Experience
- Proven experience in a QA role within the medical device industry
- Strong working knowledge of FDA regulations (21 CFR Part 820) and CE Mark requirements (MDR/IVDR)
- Experience preparing for and managing regulatory audits and inspections
- Hands-on experience implementing and maintaining a Quality Management System (ISO 13485)
- Familiarity with additive manufacturing processes and associated quality considerations
- Understanding of orthopaedic or implantable device regulations (desirable)
QA Engineer employer: Lynx Recruitment Ltd
Contact Detail:
Lynx Recruitment Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Engineer
✨Tip Number 1
Network like a pro! Reach out to folks in the MedTech industry, especially those working in QA roles. LinkedIn is your best mate here; connect with people and don’t be shy to ask for informational chats.
✨Tip Number 2
Show off your skills! Prepare a portfolio or case studies that highlight your experience with FDA regulations and ISO 13485. This will give you an edge during interviews and show that you mean business.
✨Tip Number 3
Practice makes perfect! Get ready for those tricky interview questions by doing mock interviews with friends or using online platforms. Focus on your experience with audits and CAPA processes to impress the hiring team.
✨Tip Number 4
Don’t forget to apply through our website! We’re always on the lookout for talented QA Engineers like you. Keep an eye on our job postings and make sure your application stands out!
We think you need these skills to ace QA Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the QA Engineer role. Highlight your experience in the medical device industry and any specific knowledge of FDA regulations and ISO standards. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance in MedTech and how you can contribute to our mission. Keep it concise but impactful, and don’t forget to mention your relevant experiences.
Showcase Your Achievements: When detailing your past roles, focus on your achievements rather than just responsibilities. Did you improve a process or lead a successful audit? We love to see quantifiable results that demonstrate your impact in previous positions.
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 at StudySmarter!
How to prepare for a job interview at Lynx Recruitment Ltd
✨Know Your Regulations
Make sure you brush up on FDA regulations and CE Mark requirements before the interview. Being able to discuss these in detail will show that you’re not just familiar with them, but that you understand their importance in maintaining quality standards.
✨Showcase Your QMS Experience
Prepare specific examples of how you've implemented or improved a Quality Management System in your previous roles. This is crucial for a QA Engineer position, so be ready to discuss your hands-on experience with ISO 13485 and any challenges you faced.
✨Audit Preparedness
Since you'll be involved in audits, it’s essential to demonstrate your experience with internal and external audits. Share stories about how you prepared for these audits and what you learned from them to highlight your proactive approach.
✨Continuous Improvement Mindset
Be ready to talk about initiatives you've led or contributed to that drove continuous improvement in quality processes. Companies love candidates who can think critically and suggest ways to enhance quality, so come armed with ideas and examples!
