At a Glance
- Tasks: Lead design control and risk management for innovative medical devices.
- Company: Join a global pharmaceutical leader in a dynamic research environment.
- Benefits: Competitive pay, hands-on experience, and opportunities for professional growth.
- Other info: Collaborative team culture with a focus on innovation and quality.
- Why this job: Make a real impact on healthcare by ensuring product quality and compliance.
- Qualifications: Degree in science with relevant experience in the pharmaceutical 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 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, Compliance in Kent employer: TekWissen
TekWissen is an exceptional employer, offering a dynamic work environment in the heart of Sandwich, UK, where innovation meets compliance in the pharmaceutical sector. Employees benefit from a culture that prioritises collaboration and professional growth, with opportunities to engage in cutting-edge biotherapeutics projects while ensuring adherence to quality and regulatory standards. With a commitment to diversity and inclusion, TekWissen fosters a supportive atmosphere that empowers Quality Engineers to thrive and make a meaningful impact in their field.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Engineer, Compliance in Kent
✨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 compliance standards and be ready to discuss how your experience aligns with their needs. Show them you’re not just another candidate!
✨Tip Number 3
Practice your responses to common interview questions, especially those related to design control and risk management. We want you to feel confident and articulate when discussing your expertise in these areas.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take that extra step to engage with us directly.
We think you need these skills to ace Quality Engineer, Compliance in Kent
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Engineer role. Highlight your experience with design controls and risk management, and don’t forget to mention any relevant qualifications like ISO certifications. 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 compliance in the pharmaceutical industry. Share specific examples of your past work that relate to the job description. We love seeing your personality come through!
Showcase Your Technical Skills:Don’t hold back on showcasing your technical skills! Mention your familiarity with ISO standards and any experience with human factors engineering. We’re keen to see how your expertise aligns with our needs, so be specific!
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 directly and ensures you don’t miss out on any important updates. Let’s get your journey started!
How to prepare for a job interview at TekWissen
✨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 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 a friend to refine your delivery.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to quality management and how they handle regulatory compliance. This shows your genuine interest in the role and helps you assess if the company aligns with your values.
