Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead design control and risk management for medical device development.
- Company: Join a leading Pharmaceutical company in a hybrid work environment.
- Benefits: Competitive hourly rate, flexible remote work, and career advancement opportunities.
- Why this job: Make a real impact in healthcare by ensuring product quality and compliance.
- Qualifications: Degree in science or engineering and experience with pharmaceutical products.
- Other info: Exciting 12-month contract with a focus on innovation and quality.
We are recruiting a Quality Engineer to join a leading Pharmaceutical company based in Cambridgeshire. As the Quality Engineer, you will play a crucial role in ensuring the design control and risk management of medical device and combination product development programmes throughout their lifecycle.
Please note this is an initial 12 month contract and hybrid working (2-3 days remote per week).
KEY DUTIES AND RESPONSIBILITIES:- Lead design control and risk management activities for combination product development programmes, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
- Support and facilitate effective risk management activities at external design companies and manufacturing facilities related to assigned projects.
- Ensure combination product development activities are compliant with quality and regulatory standards, both internal and external.
- Provide input and support to design validation including, but not limited to, human factors engineering assessments.
- Relevant degree in a science or engineering discipline such as chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, or chemical engineering.
- Proven industry experience with pharmaceutical combination products.
- A working knowledge and practical experience with ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
Quality Engineer employer: Hyper Recruitment Solutions LTD
Contact Detail:
Hyper Recruitment Solutions LTD Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Engineer
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharmaceutical and engineering sectors on LinkedIn. Join relevant groups, participate in discussions, and don’t hesitate to ask for informational interviews. We all know that sometimes it’s not just what you know, but who you know!
✨Tip Number 2
Prepare for those interviews by researching the company and its products. Understand their quality standards and recent projects. We want you to be able to discuss how your experience aligns with their needs, especially around design control and risk management.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors. Focus on articulating your experience with ISO standards and combination products. We’re here to help you feel confident and ready to impress!
✨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 take the initiative. Let’s get you that Quality Engineer role!
We think you need these skills to ace Quality Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Engineer role. Highlight your relevant experience with pharmaceutical combination products and any specific projects that align with the key duties mentioned in the job description.
Showcase Your Skills: Don’t forget to showcase your knowledge of ISO standards and regulatory compliance. We want to see how your skills match up with what we’re looking for, so be specific about your experience with ISO 13485 and 21 CFR regulations.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality engineering in the pharmaceutical sector and how your background makes you a perfect fit for this role. Keep it engaging and to the point!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates regarding your application status.
How to prepare for a job interview at Hyper Recruitment Solutions LTD
✨Know Your Standards
Familiarise yourself with ISO 13485, ISO 14971, and the relevant regulations. Be ready to discuss how you've applied these standards in your previous roles, as this will show your understanding of compliance in quality engineering.
✨Showcase Your Experience
Prepare specific examples from your past work with pharmaceutical combination products. Highlight your role in design control and risk management activities, as this will demonstrate your hands-on experience and relevance to the position.
✨Ask Insightful Questions
Think of questions that reflect your interest in the company's projects and their approach to quality assurance. This not only shows your enthusiasm but also helps you gauge if the company aligns with your career goals.
✨Practice Human Factors Engineering
Brush up on human factors engineering assessments and be prepared to discuss how they impact design validation. This is a key aspect of the role, and demonstrating your knowledge here can set you apart from other candidates.
