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 York 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 York
✨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 a Quality Engineer role. You never know who might have the inside scoop on an opportunity that’s not even advertised yet!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO 13485 and validation processes. We recommend creating a cheat sheet with key points and examples from your past experience to showcase your expertise during the interview.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a quick thank-you email to express your appreciation and reiterate your interest in the role. It keeps you fresh in their minds and shows your enthusiasm.
✨Tip Number 4
Apply through our website for the best chance at landing that Quality Engineer gig! We make it easy for you to showcase your skills and experience directly to the hiring team, so don’t miss out on that opportunity.
We think you need these skills to ace Quality Engineer in York
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 love seeing candidates who can demonstrate their expertise in ISO 13485 and CAPA implementation!
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss any important updates. 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 validation processes. Be ready to discuss your past experiences in the medical device industry, especially any specific projects you've led or contributed to. This will show that you’re not just familiar with the concepts but have practical experience too.
✨Prepare for Technical Questions
Expect some technical questions related to quality engineering, such as how you would approach a CAPA implementation or conduct a root cause analysis. Practise articulating your thought process clearly and confidently, as this will demonstrate your problem-solving skills and expertise.
✨Show Your Team Spirit
Since the role involves collaboration, be prepared to discuss how you’ve worked with cross-functional teams in the past. Share examples of how you’ve supported projects or driven continuous improvement initiatives, highlighting your communication skills and ability to work well with others.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! Inquire about the company’s current quality challenges or their approach to risk management. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.
