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- Tasks: Ensure quality and compliance for medical devices throughout their lifecycle.
- Company: Join a leading Biotherapeutics Pharmaceutical R&D team in Cambridge.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact on healthcare by ensuring the highest standards of quality.
- Qualifications: BSc/MSc/PhD in relevant fields and 2 years experience in medical devices.
- Other info: Collaborative environment with strong focus on innovation and career development.
The predicted salary is between 36000 - 60000 £ per year.
Location: Cambridge, UK (Hybrid 2.5 days per week onsite)
About the Role
Join the Biotherapeutics Pharmaceutical R&D Devices Centre of Excellence, where you'll play a key role in ensuring quality and compliance for medical devices and combination products throughout their lifecycle. This position focuses on design control and risk management, supporting development programs from early design through to commercial launch. You'll work closely with cross-functional teams and external partners to maintain the highest standards of quality and regulatory compliance.
Key Responsibilities
- Lead design control and risk management activities for combination product development, ensuring all deliverables are accurate, approved, and audit ready.
- Facilitate risk management processes with external design and manufacturing partners.
- Ensure compliance with internal and external quality and regulatory standards (ISO 13485, ISO 14971, 21 CFR 820, EU MDR).
- Provide input into design validation activities, including Human Factors Engineering assessments.
- Assess external suppliers for quality system capability and compliance.
- Support investigations into device issues from clinical trials and commercial manufacturing.
- Contribute to regulatory submissions for assigned device projects.
- Assist with internal and external audits of the Device Centre of Excellence Quality Management System.
Education & Experience
- BSc/MSc/PhD in a relevant science or engineering discipline (e.g., Chemistry, Biology, Biomedical Sciences, Mechanical or Chemical Engineering).
- Minimum 2 years experience in pharmaceutical combination product and/or medical device industries.
- Proven experience in design controls and risk management for combination products.
- Familiarity with Human Factors Engineering and device assembly/manufacturing processes.
- Strong working knowledge of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, EU MDR.
Technical Skills
- Understanding of EN 62366, EN 60601, EN 62304 standards.
- Ability to apply established procedures consistently and accurately.
- Strong attention to detail, organizational skills, and ability to manage multiple priorities.
- Excellent communication and interpersonal skills; able to work collaboratively in cross-functional teams.
- Proficiency in MS Office and general computer applications.
- Knowledge of GMP principles.
Key Competencies
- Decisive: Synthesizes complex information to make informed decisions.
- Focused: Holds self and others accountable for delivering results.
- Connected: Builds strong relationships with internal and external stakeholders.
- Courageous: Demonstrates integrity and consistency between words and actions.
- Resilient: Adapts quickly to changing priorities and business needs.
Quality Engineer in Cambridge employer: Next Phase
Contact Detail:
Next Phase Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Engineer in Cambridge
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect with professionals on LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their quality standards and compliance requirements. This will help you showcase your knowledge and passion for the role during the interview.
✨Tip Number 3
Practice common interview questions related to design control and risk management. We recommend doing mock interviews with friends or mentors to build confidence and refine your answers.
✨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 Quality Engineer in Cambridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Engineer role. Highlight your experience in design control and risk management, and don’t forget to mention any relevant standards you’re familiar with, like ISO 13485 or EU MDR.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality and compliance in medical devices. Share specific examples of how you've contributed to projects in the past.
Showcase Your Technical Skills: Don’t hold back on showcasing your technical skills! Mention your proficiency in MS Office and any other relevant software. If you’ve worked with Human Factors Engineering or GMP principles, make sure to include that too!
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to keep track of your application status directly!
How to prepare for a job interview at Next Phase
✨Know Your Standards
Familiarise yourself with ISO 13485, ISO 14971, and other relevant standards before the interview. Being able to discuss these in detail will show that you understand the compliance landscape and are ready to contribute from day one.
✨Showcase Your Experience
Prepare specific examples from your past work that highlight your experience in design controls and risk management. Use the STAR method (Situation, Task, Action, Result) to structure your answers and make them impactful.
✨Communicate Effectively
Practice articulating complex technical concepts in a clear and concise manner. Since you'll be working with cross-functional teams, demonstrating strong communication skills will be key to showing you can collaborate effectively.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to quality and compliance. This not only shows your interest in the role but also gives you a chance to assess if the company aligns with your values and career goals.