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For Companies At a Glance
- Tasks: Ensure top-notch quality for innovative orthopaedic 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 team environment with a focus on continuous improvement and career development.
The predicted salary is between 36000 - 60000 £ per year.
About Us
We are 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 are looking for a talented QA Engineer to help us maintain the highest standards of quality and regulatory compliance.
As a QA Engineer, you will play a critical role in ensuring our orthopaedic products meet regulatory requirements and quality standards. You will 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 in City of London employer: Lynx Recruitment Ltd
Contact Detail:
Lynx Recruitment Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Engineer in City of London
✨Tip Number 1
Network like a pro! Reach out to folks in the MedTech industry, especially those working with orthopaedic devices. LinkedIn is your best mate here; connect, engage, and don’t be shy to ask for informational chats.
✨Tip Number 2
Prepare for interviews by brushing up on FDA regulations and ISO standards. We want you to be the go-to person for quality management discussions. Practice common QA scenarios and think about how you’d tackle real-world challenges.
✨Tip Number 3
Showcase your hands-on experience! Bring examples of past projects where you’ve improved quality systems or managed audits. We love seeing how you’ve made a difference in previous roles, so have those stories ready.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always looking for passionate individuals who are eager to contribute to our mission in advancing orthopaedic care.
We think you need these skills to ace QA Engineer in City of London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in QA roles, especially within the medical device industry. We want to see how your skills align with our needs, so don’t be shy about showcasing your knowledge of FDA regulations and ISO standards!
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. We love seeing genuine enthusiasm for improving patient outcomes.
Showcase Relevant Experience: When detailing your past roles, focus on specific achievements that relate to regulatory compliance and quality management systems. We’re keen to know how you’ve handled audits or improved processes in your 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 serious about joining our team!
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 specific regulations like 21 CFR Part 820 and ISO 13485 will show that you’re not just familiar with the standards, but that you can apply them in real-world scenarios.
✨Showcase Your Experience
Prepare to share concrete examples from your previous QA roles, especially those related to medical devices. Highlight your experience with regulatory audits, CAPA processes, and maintaining a Quality Management System. This will demonstrate your hands-on knowledge and problem-solving skills.
✨Ask Insightful Questions
Don’t forget to prepare some thoughtful questions about the company’s quality processes and their approach to continuous improvement. This shows your genuine interest in the role and helps you gauge if the company’s values align with yours.
✨Be Ready for Technical Discussions
Since this role involves working closely with R&D and manufacturing teams, be prepared to discuss technical aspects of quality assurance in orthopaedic products. Familiarise yourself with additive manufacturing processes and how they impact quality compliance, as this could come up during the interview.
