At a Glance
- Tasks: Lead design control and risk management for innovative medical devices.
- Company: Join a global pharmaceutical leader in Cambridge, UK.
- Benefits: Competitive pay, onsite work, and opportunities for professional growth.
- Other info: Dynamic team environment with a focus on innovation and collaboration.
- Why this job: Make a real impact in healthcare by ensuring product quality and compliance.
- Qualifications: Degree in science or engineering with relevant experience in the industry.
The predicted salary is between 28000 - 35000 € 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 (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)
- PhD in appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering; or other related 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.
Quality Engineer, Compliance in Cambridge employer: TekWissen UK
TekWissen is an exceptional employer, offering a dynamic work environment in the heart of Cambridge, UK, where innovation meets compliance in the pharmaceutical and biotechnology sectors. Employees benefit from a culture that prioritises collaboration and professional growth, with opportunities to engage in cutting-edge projects that shape the future of medical devices. With a commitment to diversity and inclusion, TekWissen fosters a supportive atmosphere that empowers Quality Engineers to excel in their roles while contributing to meaningful advancements in healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Engineer, Compliance in Cambridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about asking for introductions. We all know that sometimes it’s not just what you know, but who you know that can land you that Quality Engineer role.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their compliance standards and be ready to discuss how your experience aligns with their needs. We want you to shine and show them why you’re the perfect fit for their team!
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to get comfortable with common questions. We can help you refine your answers so you can confidently showcase your design control and risk management expertise.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we’re always on the lookout for talented individuals like you to join our team in the pharmaceutical and device industries.
We think you need these skills to ace Quality Engineer, Compliance 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 qualifications like your BSc or MSc. We want to see how your background fits 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 compliance in the pharmaceutical industry. Share specific examples of your past work that align with the responsibilities listed in the job description. We love a good story!
Showcase Your Technical Skills:Don’t hold back on showcasing your technical skills! Mention your familiarity with ISO standards and any experience you have with human factors engineering. We’re keen to see how you can contribute to our team’s success in ensuring quality and compliance.
Apply Through Our Website:We encourage you to apply 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. Plus, it’s super easy to do!
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. Being able to discuss these standards confidently will show that you understand the compliance landscape and can contribute effectively to the role.
✨Showcase Your Experience
Prepare specific examples from your past work where you've led design control or risk management activities. Highlight how you ensured compliance and supported clinical trials, as this will demonstrate your hands-on experience in the pharmaceutical industry.
✨Communicate Clearly
Practice articulating complex technical concepts in a straightforward manner. Since the role involves cross-functional teamwork, being able to communicate effectively with diverse teams is crucial. Consider doing mock interviews to refine your delivery.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to quality management and their current projects. This not only shows your interest but also gives you a chance to assess if the company aligns with your career goals.
