At a Glance
- Tasks: Lead design control and risk management for innovative medical devices.
- Company: Join a world-renowned biopharma organisation in Cambridge.
- Benefits: Competitive rate of £28.20 per hour plus holiday entitlement.
- Other info: Hybrid work model with 2.5 days onsite, offering great career growth.
- Why this job: Make a real impact in the development of cutting-edge medical products.
- Qualifications: Degree in Engineering or Life Sciences; experience in medical devices preferred.
The predicted salary is between 56000 - 64000 € per year.
Atrium (EMEA) is partnering with a leading global biopharma organisation to hire a Quality Engineer. The candidate will provide design control and risk management subject matter expertise to medical device and combination product development programmes throughout the product lifecycle.
Key Responsibilities
- Lead design control and risk management activities for product development programmes
- Ensure compliance with regulatory and quality standards (ISO, FDA, EU MDR)
- Prepare and review design history files and risk management documentation
- Support design validation activities, including human factors engineering
- Collaborate with external partners, suppliers, and manufacturing sites
- Contribute to regulatory submissions and audit readiness
- Assist with device investigations for clinical and commercial products
What We’re Looking For
- Degree (BSc/MSc/PhD) in Engineering, Life Sciences, or related discipline
- Experience in medical devices or combination products
- Strong knowledge of design controls & risk management
- Familiarity with standards such as: ISO 13485, ISO 14971, 21 CFR 820 / 21 CFR Part 4 EU Medical Devices Regulation
- Understanding of Human Factors / Usability Engineering
- Knowledge of GMP and quality systems
Why Apply?
- Work with a world-renowned pharmaceutical organisation
- Gain exposure to cutting-edge device and combination product development
- Collaborative and innovative environment
Quality Engineer employer: Atrium
Join a world-renowned pharmaceutical organisation in Cambridge, where you will thrive in a collaborative and innovative environment. As a Quality Engineer, you will not only contribute to cutting-edge device development but also enjoy competitive pay and holiday entitlement, alongside opportunities for professional growth within a company that values compliance and quality standards. Experience the unique advantage of hybrid working, allowing you to balance your professional and personal life effectively.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Engineer
✨Tip Number 1
Network like a pro! Reach out to folks in the pharma and medical device sectors on LinkedIn. A friendly message can go a long way, and you never know who might have the inside scoop on job openings.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of design controls and risk management. We recommend practising common interview questions related to ISO standards and human factors engineering to show you're the right fit.
✨Tip Number 3
Don’t just apply and wait! Follow up with a quick email or message to express your enthusiasm for the role. It shows initiative and keeps you on their radar.
✨Tip Number 4
Make sure to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are keen to join us directly.
We think you need these skills to ace Quality Engineer
Some tips for your application 🫡
Read the Job Description Thoroughly:Before you start your application, make sure to read through the job description carefully. We want to see that you understand what the role entails and how your skills align with the requirements. Highlighting relevant experience will make your application stand out!
Tailor Your CV and Cover Letter:Don’t just send a generic CV! We recommend tailoring your CV and cover letter to reflect the specific skills and experiences that match the Quality Engineer role. Use keywords from the job description to show that you’re a perfect fit for the position.
Showcase Your Relevant Experience:When detailing your experience, focus on your background in medical devices or combination products. We love to see examples of your work with design controls and risk management, so don’t hold back on sharing those achievements!
Apply Through Our Website:Once you’ve polished your application, head over to our website to submit it. Applying directly through our site ensures that your application gets to the right people quickly. Plus, it’s super easy to do!
How to prepare for a job interview at Atrium
✨Know Your Standards
Make sure you brush up on the key regulatory standards like ISO 13485 and ISO 14971. Being able to discuss these in detail will show that you’re not just familiar with them, but that you understand how they apply to the role of a Quality Engineer.
✨Showcase Your Experience
Prepare specific examples from your past work that highlight your experience with design control and risk management. Use the STAR method (Situation, Task, Action, Result) to structure your answers and make them impactful.
✨Understand Human Factors Engineering
Since the role involves design validation activities, be ready to talk about human factors engineering. Think of examples where you’ve considered usability in product design and how it impacted the outcome.
✨Collaborate and Communicate
This position requires collaboration with external partners and suppliers. Be prepared to discuss how you’ve successfully worked in teams and communicated effectively in previous roles, especially in high-stakes environments like medical devices.
