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For Companies At a Glance
- Tasks: Lead risk management and ensure compliance in medical device development.
- Company: Join a global pharmaceutical organisation based in Cambridge.
- Benefits: Competitive PAYE contract with a minimum term of 6 months.
- Why this job: Make a real impact on innovative medical products and enhance patient safety.
- Qualifications: BSc in science/engineering with 5+ years in pharmaceutical/device industries.
- Other info: Collaborative environment with opportunities for professional growth.
The predicted salary is between 36000 - 60000 £ per year.
Overview
Senior Consultant @ Cpl Life Sciences – Contract Engineering UK/EU
Cpl Life Sciences are looking to recruit a Quality & Compliance Engineer to join a global Pharmaceutical organisation based in Cambridge. This role sits within their combination product team – combination product or medical device experience are highly desirable.
This role will provide design control and risk management expertise to medical device and combination product development projects, from initial design through to manufacturing. This role heavily involves generation and review of DHF/risk management files, working alongside device development leads, design engineers and human factors SMEs.
This role is a PAYE contract – with a minimum term of 6 months. You will be expected to be present at the Cambridge site.
Responsibilities
- Lead risk management (ISO 14971) and design control activities.
- Ensure product development activities are compliant with quality and regulatory standards.
- Provide support to design validation/human factors engineering teams.
- Support design and manufacturing investigations.
- Support internal and external audits from a product development engineering stance.
Qualifications
- BSc in appropriate science & engineering discipline with a minimum of 5 years of relevant experience in the pharmaceutical combination product and/or device industries
- Knowledge of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
- Ideally experience in design controls for combination products.
- Familiar with Human Factors Engineering – Usability Engineering.
- Familiar with medical device manufacturing processes.
How to apply
If interested, please apply directly or email your CV to megan.smyth@cpl.com
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Quality Compliance Engineer employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Compliance Engineer
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those who work at companies you're interested in. A friendly chat can open doors and give you insider info on job openings.
✨Tip Number 2
Prepare for interviews by practising common questions related to quality compliance and design control. We recommend doing mock interviews with friends or using online platforms to boost your confidence.
✨Tip Number 3
Showcase your expertise! Bring along examples of your previous work, especially any projects involving ISO standards or risk management. This will help you stand out as a candidate who knows their stuff.
✨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 Compliance Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Compliance Engineer role. Highlight your experience with ISO standards and any relevant projects you've worked on in the pharmaceutical or medical device sectors.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role, focusing on your design control and risk management expertise. Don't forget to mention your passion for quality compliance!
Showcase Relevant Experience: When detailing your work history, emphasise your experience with combination products and any specific projects that align with the responsibilities listed in the job description. We want to see how you can contribute to our team!
Apply Through Our Website: We encourage you to apply directly through our website for a smoother application process. It helps us keep track of your application and ensures you don’t miss out on any important updates!
How to prepare for a job interview at Cpl Life Sciences
✨Know Your Standards
Familiarise yourself with ISO 13485, ISO 14971, and the EU Medical Devices Regulation. Being able to discuss these standards confidently will show that you understand the compliance landscape and can navigate it effectively.
✨Showcase Your Experience
Prepare specific examples from your past roles where you've led risk management or design control activities. Use the STAR method (Situation, Task, Action, Result) to structure your answers and highlight your contributions.
✨Understand the Product Lifecycle
Brush up on the entire lifecycle of combination products and medical devices. Be ready to discuss how you’ve contributed to each phase, from initial design through to manufacturing, and how you ensure compliance at every step.
✨Engage with Human Factors
Since the role involves working with human factors engineering, be prepared to discuss usability engineering principles. Share any relevant experiences where you’ve considered user interaction in product design, as this will demonstrate your holistic approach to quality compliance.
