At a Glance
- Tasks: Lead validation programmes and ensure compliance in the medical device industry.
- Company: Join a leading medical device company in Yorkshire with a focus on quality.
- Benefits: Gain valuable experience in a contract role with potential for future opportunities.
- Other info: Onsite role with a dynamic team and a chance to drive continuous improvement.
- Why this job: Make a real impact on patient safety and product quality in healthcare.
- Qualifications: Experience in quality engineering and knowledge of ISO 13485 required.
The predicted salary is between 40000 - 50000 € per year.
We are looking for an experienced Quality Engineer from the medical device industry to start at short notice on a 6 – 9 month contract. The role is site based 5 days a week.
Responsibilities:
- Lead and implement validation programmes, including process, cleaning, sterilisation, and computerised systems validation
- Develop and review validation protocols and reports, ensuring robust statistical analysis and data integrity
- Generate and review equipment qualifications and Gauge R&R studies
- Support site qualification activities aligned to the Master Validation Plan
- Investigate complex quality and compliance issues, driving root cause analysis and CAPA implementation
- Lead risk management activities (e.g. FMEA) and integrate risk processes across the product lifecycle
- Provide quality engineering support to projects, ensuring timely and compliant delivery
- Drive continuous improvement initiatives to enhance systems, processes, and efficiency
- Support maintenance, calibration, and equipment compliance systems
- Participate in internal and supplier audits, ensuring regulatory compliance
Requirements:
- Significant experience working as a Quality Engineer in the medical device industry.
- Availability to start with short notice.
- Ability to work onsite 5 days per week.
- Eligibility to work in the UK for a full duration of the contract.
- Excellent communication skills.
- A good knowledge of ISO 13485.
- Equipment and process qualification and validation experience.
Quality Engineer in Middlesbrough employer: Kinetica
As a Quality Engineer in the heart of Yorkshire's thriving medical device sector, you will join a company that prioritises employee development and fosters a collaborative work culture. With a focus on continuous improvement and compliance, this role offers the opportunity to engage in meaningful projects while benefiting from a supportive environment that encourages professional growth and innovation.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Engineer in Middlesbrough
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device industry and let them know you're on the lookout for Quality Engineer roles. You never know who might have the inside scoop on a job opening or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO 13485 and validation processes. We recommend practising common interview questions related to quality engineering, so you can showcase your expertise and experience confidently.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Use our website to find roles that excite you, and tailor your approach to each company’s culture and mission.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. It shows your enthusiasm for the role and gives you another chance to highlight why you’re the perfect fit for their team.
We think you need these skills to ace Quality Engineer in Middlesbrough
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Quality Engineer role. Highlight your experience in the medical device industry and any relevant projects you've worked on. 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 the perfect fit for this contract. Mention specific experiences that relate to the responsibilities listed in the job description, and don’t forget to show your enthusiasm for the role.
Showcase Your Skills:When filling out your application, make sure to showcase your skills in validation programmes, risk management, and compliance. We’re keen on seeing how you’ve tackled complex quality issues in the past, so give us the details!
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of applications and ensures you get all the updates directly from us. Plus, it’s super easy!
How to prepare for a job interview at Kinetica
✨Know Your Stuff
Make sure you brush up on your knowledge of ISO 13485 and the specific validation processes relevant to the medical device industry. Be ready to discuss your past experiences with equipment qualifications and CAPA implementation, as these will likely come up during the interview.
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've tackled complex quality and compliance issues in the past. Use the STAR method (Situation, Task, Action, Result) to structure your answers, highlighting your ability to drive root cause analysis and implement effective solutions.
✨Be Ready for Technical Questions
Expect technical questions related to validation programmes and risk management activities like FMEA. Brush up on your understanding of statistical analysis and data integrity, as these are crucial for the role. Practising with a friend or mentor can help you articulate your thoughts clearly.
✨Demonstrate Your Team Spirit
Since this role involves collaboration with various teams, be prepared to discuss how you've worked effectively with others in previous roles. Highlight any experience you have in leading projects or supporting site qualification activities, showing that you're a team player who can drive continuous improvement.
