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- Tasks: Join a dynamic team as a QA Specialist, ensuring top-notch quality in MedTech products.
- Company: Be part of an innovative MedTech company transforming ear and hearing healthcare.
- Benefits: Enjoy a collaborative work environment with opportunities for growth and development.
- Why this job: Make a real impact in health technology while working on exciting projects.
- Qualifications: BSc in Science, proven QA experience, and knowledge of ISO 13485 required.
- Other info: Ideal for those passionate about quality assurance in the medical device industry.
The predicted salary is between 36000 - 60000 £ per year.
Cure Talent is delighted to be working with an innovative MedTech company revolutionising ear and hearing healthcare! With their ongoing growth and exciting projects, we have a fantastic opportunity for a QA Specialist to join their highly motivated team.
As a QA Specialist, you will play a key role in maintaining and continuously improving the ISO 13485 QMS. You will oversee Quality Events, CAPAs, Change Controls, and Quality Metrics while supporting compliance with QSR, ISO, CE, and other global regulatory requirements.
Key Responsibilities:
- Maintain and improve the ISO 13485 QMS.
- Oversee Quality Events, including deviations, non-conformances, CAPAs, and Change Controls.
- Generate and revise SOPs and associated documentation.
- Support regulatory compliance activities, including audits, customer complaints, and employee training.
- Generate and maintain Design History Files and Technical Documentation to support global market registrations.
- Participate in risk management activities, ensuring effective risk mitigation in products and processes.
The Ideal Candidate Will Have:
- BSc in Science or a related field.
- Proven Quality Assurance experience within the Medical Device industry.
- Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR.
- Experience with EN 62304 (desirable).
- Certified Internal or Lead ISO 13485 Auditor.
- Experience using an eQMS.
If you're looking for an exciting opportunity to be part of a rapidly expanding company at the forefront of health technology innovation, get in touch today!
Quality Assurance Specialist employer: Cure Talent
Contact Detail:
Cure Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Specialist
✨Tip Number 1
Familiarize yourself with the ISO 13485 QMS and other relevant regulations like FDA 21 CFR Part 820 and EU MDR. Understanding these standards will not only help you in interviews but also demonstrate your commitment to quality assurance in the MedTech industry.
✨Tip Number 2
Network with professionals in the Medical Device industry, especially those who have experience in Quality Assurance. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in quality management.
✨Tip Number 3
Prepare to discuss specific examples of how you've handled Quality Events, CAPAs, and Change Controls in your previous roles. Being able to articulate your hands-on experience will set you apart from other candidates.
✨Tip Number 4
Stay updated on the latest developments in eQMS tools and software. Familiarity with these systems can give you an edge, as many companies are looking for candidates who can seamlessly integrate into their existing processes.
We think you need these skills to ace Quality Assurance Specialist
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Quality Assurance Specialist position. Understand the key responsibilities and required qualifications, especially regarding ISO 13485 and regulatory compliance.
Tailor Your CV: Customize your CV to highlight your relevant experience in Quality Assurance within the Medical Device industry. Emphasize your knowledge of ISO standards and any specific projects that align with the company's focus on ear and hearing healthcare.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance and your understanding of the MedTech industry. Mention specific experiences that demonstrate your ability to maintain and improve QMS and support regulatory compliance.
Highlight Certifications: If you have certifications such as Certified Internal or Lead ISO 13485 Auditor, make sure to prominently feature them in your application. This will strengthen your candidacy and show your commitment to quality standards.
How to prepare for a job interview at Cure Talent
✨Show Your Knowledge of ISO Standards
Make sure to brush up on ISO 13485 and other relevant standards before the interview. Be prepared to discuss how you've applied these standards in your previous roles, as this will demonstrate your expertise and understanding of quality management systems.
✨Prepare for Scenario-Based Questions
Expect questions that ask you to describe how you would handle specific quality events or compliance issues. Think of examples from your past experience where you successfully managed deviations, CAPAs, or change controls, and be ready to explain your thought process.
✨Highlight Your Regulatory Knowledge
Since the role involves supporting compliance with various regulations, be prepared to discuss your experience with FDA regulations, EU MDR, and any audits you've participated in. This will show that you are well-versed in the regulatory landscape of the medical device industry.
✨Demonstrate Your Team Collaboration Skills
Quality Assurance often requires working closely with other departments. Be ready to share examples of how you've collaborated with cross-functional teams to improve quality processes or resolve issues, showcasing your ability to work effectively in a team environment.
