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- Tasks: Lead quality assurance for innovative medical devices and enhance product development processes.
- Company: Join Kinetica, a leading diagnostics company with a focus on quality and innovation.
- Benefits: Full-time role with opportunities for career growth and professional development.
- Why this job: Make a real difference in healthcare by ensuring top-notch product quality.
- Qualifications: Experience in medical device development and strong knowledge of design controls required.
- Other info: Be part of a newly formed team in a dynamic and collaborative environment.
The predicted salary is between 36000 - 60000 £ per year.
Kinetica is looking for a quality professional with extensive experience in compliance for product development and design control, to work for a leading diagnostics company. This is a fully site-based role within a newly formed team.
Responsibilities:
- Support site projects that drive new product development (NPD) and product lifecycle management (PLCM).
- Provide Design Control leadership and collaborate across LBS and Danaher sites.
- Improve processes to reduce variability and strengthen product robustness.
- Lead functional teams or medium-scale projects as needed.
- Partner with Regulatory Affairs on global submissions, including FDA 510(k), PMA, and IVDR CE documentation.
Requirements:
- Strong knowledge of Design Controls and design/development practices for medical device or diagnostic products.
- Extensive experience in medical device development and quality systems.
- Expert understanding of standards such as 21 CFR 820, ISO 13485, ISO 14971, and MDSAP.
- Proven Quality leadership experience.
- Bachelor’s degree in a scientific or technical discipline.
Employment type: Full-time
Job function: Quality Assurance and Research
Industries: Medical Equipment Manufacturing, Measuring and Control Instrument Manufacturing, Biotechnology Research
Design Assurance Engineer in North East employer: Kinetica
Contact Detail:
Kinetica Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Design Assurance Engineer in North East
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those at Kinetica. A friendly chat can open doors and give you insights that a job description just can't.
✨Tip Number 2
Prepare for the interview by brushing up on your knowledge of design controls and quality systems. We want to see you shine when discussing standards like ISO 13485 and 21 CFR 820!
✨Tip Number 3
Showcase your leadership skills! Be ready to share examples of how you've led teams or projects in the past. We love hearing about your experiences in driving product development and improving processes.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you're serious about joining the Kinetica team.
We think you need these skills to ace Design Assurance Engineer in North East
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Design Assurance Engineer role. Highlight your experience in compliance, product development, and design control. 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 quality assurance in medical devices and how your background makes you a perfect fit for our team at Kinetica.
Showcase Relevant Experience: When filling out your application, be sure to showcase your experience with standards like ISO 13485 and 21 CFR 820. We love seeing candidates who understand the ins and outs of quality systems in the medical field.
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. We can’t wait to see what you bring to the table!
How to prepare for a job interview at Kinetica
✨Know Your Standards
Familiarise yourself with the key standards mentioned in the job description, like 21 CFR 820 and ISO 13485. Being able to discuss these in detail will show your expertise and understanding of the regulatory landscape.
✨Showcase Your Experience
Prepare specific examples from your past roles that highlight your experience in design control and quality systems. Use the STAR method (Situation, Task, Action, Result) to structure your responses effectively.
✨Collaborative Mindset
Since the role involves collaboration across teams, be ready to discuss how you've successfully worked with cross-functional teams in the past. Highlight any leadership experiences you have, especially in driving projects or improving processes.
✨Ask Insightful Questions
Prepare thoughtful questions about Kinetica's approach to product lifecycle management and their current projects. This not only shows your interest but also helps you gauge if the company aligns with your career goals.