At a Glance
- Tasks: Lead design control and risk management for innovative medical devices.
- Company: Join a leading global biopharma organisation in a hybrid work environment.
- Benefits: Competitive rate of £28.20 per hour plus holiday entitlement.
- Other info: Dynamic role with opportunities for professional growth in a world-renowned company.
- 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 in opleiding 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 in opleiding
✨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.
✨Tip Number 2
Prepare for interviews by brushing up on design control and risk management topics. We recommend practising common interview questions related to regulatory standards and human factors engineering.
✨Tip Number 3
Showcase your expertise! Create a portfolio that highlights your experience with regulatory submissions and design validation activities. This will set you apart from other candidates.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Engineer in opleiding
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Engineer role. Highlight your relevant experience in medical devices and any specific projects that showcase your design control and risk management skills. We want to see how you fit into our world!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about the role and how your background aligns with our needs. Don’t forget to mention your experience with regulatory submissions – it’s a big plus for us!
Showcase Your Knowledge:In your application, demonstrate your understanding of ISO, FDA, and EU MDR standards. We love candidates who can speak our language, so include any relevant certifications or training that highlight your expertise in quality systems.
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 makes the process smoother for everyone involved!
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. Familiarise yourself with the specifics of the job description, especially around medical devices and combination products, so you can confidently discuss your expertise.
✨Prepare for Scenario Questions
Expect to be asked about real-life scenarios related to quality engineering. Think of examples from your past experiences where you led design control activities or contributed to regulatory submissions. Use the STAR method (Situation, Task, Action, Result) to structure your answers.
✨Show Your Passion for Compliance
Demonstrate your understanding of compliance and quality standards during the interview. Be ready to discuss how you ensure adherence to regulations like EU MDR and how you approach audit readiness. This shows that you take quality seriously and are committed to maintaining high standards.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! Inquire about the company’s approach to human factors engineering or how they handle device investigations. This not only shows your interest in the role but also helps you gauge if the company is the right fit for you.
