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- Tasks: Lead the development of a Quality Management System for Medical Devices.
- Company: Growing Medical Devices company in Cambridge with a focus on innovation.
- Benefits: Opportunity for hybrid working, professional growth, and training in ISO 13485 standards.
- Why this job: Make a real impact in the Medical Devices sector and advance your career.
- Qualifications: Degree in Quality Assurance or related field; experience in ISO 9001 or QMS preferred.
- Other info: Collaborate with experts and enjoy a dynamic work environment.
The predicted salary is between 36000 - 60000 £ per year.
A growing Medical Devices company based in Cambridge is currently looking for a new Quality Assurance Specialist to assist in the development of the QMS system for ISO 13485 standards. They are open to candidates from alternative sectors, allowing for ISO 13485 standards training.
You will also be creating and managing technical files for several Medical Devices lines, including Class I, Class IIa, and Class IIb Medical Devices. You'll collaborate with a number of Medical Devices experts, but you will be the sole person focusing on Quality Assurance duties. However, you will receive Quality Assurance assistance from the parent company's Quality Assurance Manager.
We are open to candidates who only have a couple of years of experience of ISO 9001 or QMS, but also keen to hear from people with more experience. This is an excellent opportunity for someone a couple of years into their career and looking for more responsibility to lead the development of a QMS system, or for someone who is looking for a route into the Medical Devices sector under ISO 13485 standards.
Due to the active work in setting up the QMS system, you will need to be in the office daily; however, over time there should be the opportunity for hybrid working. It is expected that you would hold a degree in a subject that has led you into a Quality Assurance, Quality Engineering, or Design Assurance role.
Apart from having a Quality Assurance background, it would also be highly advantageous if you have a good understanding of Regulatory Affairs. Part of your role will involve working alongside the manufacturing teams for these medical devices. Due to this, it would be highly beneficial if your Medical Devices Quality Assurance experience came from a Quality Engineering background, although this is not essential.
I anticipate a lot of interest in this role, so if you are interested, I suggest making an application now or risk missing out.
Quality Assurance Specialist - Cambridge employer: Newton Colmore Consulting
Contact Detail:
Newton Colmore Consulting Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Specialist - Cambridge
✨Tip Number 1
Network like a pro! Reach out to professionals in the Medical Devices sector on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that Quality Assurance Specialist role.
✨Tip Number 2
Prepare for interviews by brushing up on ISO 13485 standards and the specifics of QMS systems. We recommend practising common interview questions and even doing mock interviews with friends to boost your confidence.
✨Tip Number 3
Showcase your passion for quality assurance! During interviews, share examples of how you’ve contributed to quality improvements in past roles. We want to see your enthusiasm for the field and how you can bring that to our team.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. We’re excited to hear from candidates who are eager to step into the Medical Devices sector and grow with us.
We think you need these skills to ace Quality Assurance Specialist - Cambridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Assurance role. Highlight any relevant experience, especially if you've worked with ISO standards before. We want to see how your background fits into our world of Medical Devices!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're excited about this role and how your skills can help us develop our QMS system. Be genuine and let your personality come through!
Showcase Your Passion for Quality Assurance: We love candidates who are passionate about Quality Assurance! In your application, mention any projects or experiences that demonstrate your commitment to quality and compliance. This will help us see your enthusiasm for the field.
Apply Through Our Website: Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it makes the process smoother for both of us!
How to prepare for a job interview at Newton Colmore Consulting
✨Know Your Standards
Familiarise yourself with ISO 13485 standards and how they apply to the role. Brush up on your knowledge of Quality Management Systems (QMS) and be ready to discuss how your previous experience aligns with these standards, even if it’s from a different sector.
✨Showcase Your Collaboration Skills
Since you’ll be working closely with manufacturing teams and other experts, prepare examples of how you've successfully collaborated in past roles. Highlight any experiences where teamwork led to improved quality outcomes or streamlined processes.
✨Demonstrate Your Learning Mindset
As the company is open to candidates with varying levels of experience, emphasise your eagerness to learn and adapt. Share instances where you’ve quickly picked up new skills or knowledge, especially related to Quality Assurance or regulatory affairs.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's QMS development and how you can contribute. This shows your genuine interest in the role and helps you understand the expectations better. For example, ask about the challenges they face in implementing ISO 13485 standards.
