At a Glance
- Tasks: Lead design control and risk management for innovative medical devices.
- Company: Join a leading global 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 excellent career growth.
- Why this job: Make a real impact on healthcare by ensuring product quality and compliance.
- Qualifications: Degree in Engineering or Life Sciences; experience in medical devices required.
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
- EU Medical Devices Regulation
- Understanding of Human Factors / Usability Engineering
- Knowledge of GMP and quality systems
Work with a world-renowned pharmaceutical organisation.
Engineer kwaliteit 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 excellence. 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 kwaliteit
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharma and medical device sectors on LinkedIn. Join relevant groups and engage in discussions to get your name out there and show off your expertise.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO, FDA, and EU MDR standards. We want you to be able to discuss how your experience aligns with these regulations confidently!
✨Tip Number 3
Don’t just wait for job postings! Reach out directly to companies you admire, like the one we're partnering with. Express your interest in potential roles and showcase your skills in quality engineering.
✨Tip Number 4
Apply through our website for the best chance at landing that Quality Engineer role. We make it easy for you to showcase your qualifications and connect with top employers in the industry!
We think you need these skills to ace Engineer kwaliteit
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Engineer role. Highlight your experience with design control and risk management, especially in medical devices. We want to see how your background aligns with the job description!
Showcase Relevant Experience:When writing your application, focus on your experience with regulatory submissions and compliance standards like ISO and FDA. We love seeing specific examples that demonstrate your expertise in these areas.
Be Clear and Concise:Keep your application clear and to the point. Use bullet points where possible to make it easy for us to read through your qualifications and achievements. We appreciate a well-structured application!
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 see what you bring to the table!
How to prepare for a job interview at Atrium
✨Know Your Regulations
Make sure you brush up on the key regulatory standards like ISO, FDA, and EU MDR. Being able to discuss how these apply to design control and risk management will show that you’re not just familiar with the theory but can also apply it practically.
✨Showcase Your Experience
Prepare specific examples from your past work in medical devices or combination products. Highlight your experience with writing regulatory submissions like BLA, NDA, and NbOP, as this will demonstrate your hands-on knowledge and expertise in the field.
✨Understand Human Factors
Familiarise yourself with human factors engineering and usability principles. Be ready to discuss how you’ve incorporated these into design validation activities, as this is crucial for ensuring product safety and effectiveness.
✨Be Audit Ready
Since audit readiness is a key part of the role, think about how you’ve prepared for audits in the past. Discuss any experiences you have with device investigations and how you ensured compliance with quality systems, as this will highlight your attention to detail and commitment to quality.
