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- Tasks: Lead design control and risk management for innovative medical devices in a dynamic environment.
- Company: Join a global leader in pharmaceutical and biotechnology innovation.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact on healthcare by ensuring quality in life-saving products.
- Qualifications: Degree in science or engineering with experience in pharmaceutical device industries.
- Other info: Collaborative team culture with a focus on diversity and inclusion.
The predicted salary is between 36000 - 60000 £ per year.
This position is in the Biotherapeutics Pharmaceutical Research and Development Devices Centre of Excellence located in client location. The incumbent will provide design control and risk management subject matter expertise to medical device and combination product development programmes throughout the product lifecycle. This will involve generation and review of design history file and risk management file components whilst interacting with cross functional development teams at all levels of the organisation.
POSITION RESPONSIBILITIES
- Lead design control and risk management activities for combination product development programs, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
- Support and facilitation of 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.
- Support the assessment of external design companies and suppliers for capability of quality systems, facilities, and procedures to support device development and supply.
- Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture.
- Support the generation of all regulatory submission data and content for assigned device projects.
- Support internal and external audits of the DCoE Quality Management System.
EDUCATION, SKILLS AND EXPERIENCE
- BSc in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related discipline) with a minimum of 2 years of relevant experience in the pharmaceutical combination product and/or device industries OR MSc in appropriate science & engineering discipline with a minimum of 2 years of relevant experience in the pharmaceutical combination product and/or device industries OR PhD in appropriate science & engineering discipline.
- History of working in accordance with the requirements of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
- Experience in design controls and risk management for combination products.
- Familiar with Human Factors Engineering - Usability Engineering.
- Familiar with device assembling manufacturing processes.
TECHNICAL SKILLS REQUIREMENTS
- Working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation.
- Familiarity with EN 62366, EN 60601, and EN 62304.
- Able to learn and apply established procedures in a reliable and consistent manner.
- Capable of working independently with minimal supervision.
- High level of attention to technical details and accuracy.
- Able to prioritize multiple responsibilities and to work on multiple tasks simultaneously.
- Able to work collaboratively in cross functional teams.
- Excellent communication (e.g., oral, written, presentation) and interpersonal relationship skills.
- Proficiency in general computer software such as word processing, spreadsheets, presentations.
- Understand Good Manufacturing Practices (GMP).
PHYSICAL POSITION REQUIREMENTS
- Sitting, ability to travel.
Quality Engineer, Financial Services in Cambridge employer: TekWissen UK
Contact Detail:
TekWissen UK Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Engineer, Financial Services in Cambridge
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their values and how your skills align with their needs. This will help you stand out and show that you're genuinely interested in the role.
✨Tip Number 3
Practice common interview questions and scenarios related to quality engineering. Use the STAR method (Situation, Task, Action, Result) to structure your answers and demonstrate your problem-solving skills effectively.
✨Tip Number 4
Don’t forget to follow up after interviews! A simple thank-you email can leave a lasting impression and keep you on their radar. Plus, it shows your enthusiasm for the position.
We think you need these skills to ace Quality Engineer, Financial Services 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, especially in the pharmaceutical or device industries. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your background makes you a perfect fit. Don’t forget to mention any relevant projects or experiences that align with our needs.
Showcase Your Technical Skills: We love seeing candidates who are familiar with ISO standards and regulatory requirements. Make sure to highlight your knowledge of ISO 13485, ISO 14971, and other relevant regulations in your application. This will show us you’re ready to hit the ground running!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining our team at StudySmarter!
How to prepare for a job interview at TekWissen UK
✨Know Your Standards
Familiarise yourself with ISO 13485, ISO 14971, and the EU Medical Devices Regulation. Be ready to discuss how your experience aligns with these standards, as they are crucial in the role of a Quality Engineer in the pharmaceutical industry.
✨Showcase Your Technical Skills
Prepare to talk about your hands-on experience with design controls and risk management for combination products. Bring examples of past projects where you successfully implemented these processes, highlighting your attention to detail and accuracy.
✨Communicate Effectively
Practice articulating complex technical concepts in a clear and concise manner. Since this role involves cross-functional collaboration, demonstrating strong communication skills will be key to showing you can work well with diverse teams.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving abilities in real-world situations. Think of scenarios where you had to manage risks or ensure compliance, and be ready to explain your thought process and the outcomes.