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- Tasks: Lead design control and risk management for innovative medical devices and combination products.
- Company: Join a leading American pharmaceutical and biotechnology corporation in a dynamic environment.
- Benefits: Enjoy a hybrid work model, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare by ensuring quality and compliance in product development.
- Qualifications: BSc/MSc/PhD in relevant science or engineering with 2+ years of experience.
- Other info: Collaborate with cross-functional teams and enhance your skills in a supportive culture.
The predicted salary is between 36000 - 60000 £ per year.
Location: Cambridge, UK
Duration: 12 Months
Work Type: Hybrid
Overview:
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 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.
- 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 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.
TekWissen® Group is an equal opportunity employer supporting workforce diversity.
Supplier Quality Engineer (Procurement & Supply Chain) in Cambridge employer: TekWissen UK
Contact Detail:
TekWissen UK Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Supplier Quality Engineer (Procurement & Supply Chain) 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 and risk management. The more comfortable you are with your responses, the more confident you'll feel during the actual interview.
✨Tip Number 4
Don't forget to apply through our website! It’s a great way to ensure your application gets noticed. Plus, we love seeing candidates who take the initiative to engage directly with us.
We think you need these skills to ace Supplier Quality Engineer (Procurement & Supply Chain) in Cambridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Supplier Quality Engineer role. Highlight relevant experience in design control and risk management, and don’t forget to mention any familiarity with ISO standards. We want to see how your background fits perfectly with 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 skills align with our needs. Be sure to mention your experience in the pharmaceutical industry and any specific projects that showcase your expertise.
Showcase Your Technical Skills: We love seeing candidates who can demonstrate their technical know-how. Make sure to include any relevant software or methodologies you’re familiar with, especially those related to quality management systems and regulatory compliance. This will help us understand your capabilities better!
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about our company and culture while you’re at it!
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 for the role.
✨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 applied these skills.
✨Communicate Effectively
Practice articulating complex technical concepts in a clear and concise manner. This role requires excellent communication skills, so be prepared to demonstrate your ability to convey information effectively.
✨Demonstrate Team Collaboration
Highlight your experience working in cross-functional teams. Share specific instances where you collaborated with others to achieve project goals, as teamwork is key in this position.