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- Tasks: Lead design control and risk management for innovative medical devices and combination products.
- Company: Join a global pharmaceutical leader in a dynamic, hybrid work environment.
- Benefits: Competitive salary, flexible working, and opportunities for professional growth.
- Why this job: Make a real impact on healthcare by ensuring product quality and safety.
- Qualifications: BSc/MSc/PhD in science with 2+ years in pharmaceutical or device industries.
- Other info: Collaborative culture with a focus on innovation and career advancement.
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 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 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 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 II employer: TekWissen UK
Contact Detail:
TekWissen UK Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Engineer II
✨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 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 II
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Engineer II role. Highlight your relevant experience in design control and risk management, and don’t forget to mention any specific projects that align with the job description.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about the pharmaceutical industry and how your skills can contribute to the team. Keep it concise but impactful!
Showcase Your Technical Skills: Don’t shy away from listing your technical skills! Mention your familiarity with ISO standards and any experience with human factors engineering. This will show us you’re ready to hit the ground running.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and keep track of all the amazing candidates like you!
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 regulatory landscape and can navigate it effectively.
✨Showcase Your Experience
Prepare specific examples from your past work that demonstrate your experience in design controls and risk management for combination products. Use the STAR method (Situation, Task, Action, Result) to structure your responses.
✨Communicate Clearly
Practice articulating complex technical concepts in a simple way. Since you'll be interacting with cross-functional teams, being able to communicate effectively is key. Consider doing mock interviews with friends or colleagues to refine your delivery.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to quality management and how they handle design validation. This not only shows your interest but also helps you gauge if the company aligns with your values and work style.