At a Glance
- Tasks: Lead design control and risk management for innovative medical devices.
- Company: Join a leading global biopharma organisation with a strong reputation.
- 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 healthcare industry while working on cutting-edge products.
- Qualifications: Degree in Engineering or Life Sciences and experience in medical devices.
The predicted salary is between 55000 - 60000 £ 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.
- 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
- Contribute to regulatory submissions and audit readiness
- Assist with device investigations for clinical and commercial products
Requirements:
- Degree (BSc/MSc/PhD) in Engineering, Life Sciences, or related discipline
- Experience in medical devices or combination products
- Experience of writing regulatory submissions, specifically BLA, NDA and NbOP
- Extensive knowledge of device design controls, human factors and risk management
- Strong knowledge of design controls & risk management
- Understanding of Human Factors / Usability Engineering
- Knowledge of GMP and quality systems
Work with a world-renowned pharmaceutical organisation.
Engineer gezocht employer: Atrium
As a Quality Engineer at our leading global biopharma organisation in Cambridge, you will thrive in a dynamic hybrid work environment that fosters innovation and collaboration. We prioritise employee growth through continuous learning opportunities and a supportive culture that values compliance and quality standards. Join us to make a meaningful impact in the medical device sector while enjoying competitive pay and holiday entitlement.
StudySmarter Expert Advice🤫
We think this is how you could land Engineer gezocht
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharma and engineering sectors. Attend industry events or webinars to meet potential employers and get your name out there.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of design controls and risk management. Be ready to discuss how your experience aligns with the job requirements, especially around regulatory submissions.
✨Tip Number 3
Showcase your expertise! Create a portfolio that highlights your previous work in medical devices and combination products. This can really set you apart from other candidates.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of opportunities that might just be the perfect fit for you. Plus, it’s a great way to ensure your application gets seen by the right people.
We think you need these skills to ace Engineer gezocht
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Engineer role. Highlight your experience in medical devices and any relevant projects you've worked on. We want to see how your skills match what we're looking for!
Showcase Your Expertise:In your cover letter, showcase your expertise in design control and risk management. Give us examples of how you've contributed to product development programmes and ensured compliance with regulatory standards.
Be Clear and Concise:When writing your application, be clear and concise. Use bullet points where possible to make it easy for us to read through your qualifications and experiences. We appreciate straightforward communication!
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. We can’t wait to hear from you!
How to prepare for a job interview at Atrium
✨Know Your Stuff
Make sure you brush up on your knowledge of design controls, risk management, and regulatory standards like ISO and FDA. Being able to discuss these topics confidently will show that you're not just familiar with the theory but can apply it in practice.
✨Prepare for Technical Questions
Expect some technical questions related to medical devices and combination products. Review your past experiences and be ready to explain how you've handled design validation activities or contributed to regulatory submissions. Use specific examples to illustrate your expertise.
✨Show Your Problem-Solving Skills
Quality Engineers often face unexpected challenges. Be prepared to discuss a time when you encountered a problem during a project and how you resolved it. This will demonstrate your critical thinking and adaptability, which are key in this role.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! Inquire about the company’s approach to compliance and quality assurance, or how they handle device investigations. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
