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 per week.
- Why this job: Make a real impact on healthcare through cutting-edge product development.
- Qualifications: Degree in Engineering or Life Sciences; experience in medical devices required.
The predicted salary is between 58000 - 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 Quality 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 Quality
✨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 ready to discuss how your experience aligns with the role and how you can contribute to design control and risk management activities.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that excite you! Use our website to find roles that match your skills and interests. Tailor your approach to each company’s culture and values to stand out.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way. It shows your enthusiasm for the position and keeps you fresh in their minds as they make their decision.
We think you need these skills to ace Engineer Quality
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 regulatory submissions you've worked on. We want to see how your background aligns with the job description!
Showcase Your Skills:Don’t just list your skills; demonstrate them! Use specific examples from your past work that showcase your expertise in design control, risk management, and compliance with standards like ISO and FDA. This helps us see you in action!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Explain why you're passionate about the role and how your experience makes you a perfect fit. We love seeing enthusiasm and a clear connection to our mission in your application.
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 keen to join our team!
How to prepare for a job interview at Atrium
✨Know Your Regulations
Familiarise yourself with the key regulatory standards like ISO, FDA, and EU MDR. Be ready to discuss how your experience aligns with these regulations and how you've ensured compliance in past projects.
✨Showcase Your Technical Expertise
Prepare to talk about your experience with design controls and risk management. Bring specific examples of how you've led design validation activities or contributed to regulatory submissions, especially BLA, NDA, and NbOP.
✨Demonstrate Problem-Solving Skills
Think of scenarios where you've tackled challenges in medical device development. Be ready to explain your thought process and the steps you took to resolve issues, particularly in human factors engineering.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to quality assurance and product lifecycle management. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
