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- Tasks: Join a dynamic team to enhance quality in MedTech by managing ISO 13485 QMS.
- Company: Be part of an innovative MedTech company transforming ear and hearing healthcare.
- Benefits: Enjoy a 9-month contract with potential for growth in a cutting-edge industry.
- Why this job: Make a real impact in health technology while working in a motivated environment.
- Qualifications: BSc in Science, QA experience in Medical Devices, and knowledge of ISO standards required.
- Other info: Ideal for those passionate about quality assurance and regulatory compliance.
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 on an initial 9 month contract. 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 Ltd
Contact Detail:
Cure Talent Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Specialist
✨Tip Number 1
Familiarise yourself with ISO 13485 and other relevant regulations. Understanding these standards inside out will not only help you in the interview but also demonstrate your commitment to quality assurance in the MedTech industry.
✨Tip Number 2
Network with professionals in the Medical Device sector. Attend industry events or join online forums where you can connect with QA specialists. This can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've handled Quality Events, CAPAs, and Change Controls in your previous roles. Real-life scenarios will showcase your problem-solving skills and experience effectively.
✨Tip Number 4
Stay updated on the latest trends and technologies in the MedTech field. Showing that you're knowledgeable about current advancements can set you apart from other candidates and highlight your passion for the industry.
We think you need these skills to ace Quality Assurance Specialist
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to understand the key responsibilities and qualifications required for the Quality Assurance Specialist position. Tailor your application to highlight relevant experience in maintaining ISO 13485 QMS and regulatory compliance.
Highlight Relevant Experience: In your CV and cover letter, emphasise your proven Quality Assurance experience within the Medical Device industry. Mention specific projects or tasks where you oversaw Quality Events, CAPAs, or Change Controls.
Showcase Your Knowledge: Demonstrate your strong working knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR in your application. Use examples to illustrate how you've applied this knowledge in previous roles.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also expresses your enthusiasm for the role and the company. Mention why you're excited about contributing to an innovative MedTech company and how your skills align with their mission.
How to prepare for a job interview at Cure Talent Ltd
✨Know Your Standards
Familiarise yourself with ISO 13485 and other relevant regulations like FDA 21 CFR Part 820 and EU MDR. Be prepared to discuss how you've applied these standards in your previous roles, as this will demonstrate your expertise and understanding of the quality assurance landscape.
✨Showcase Your Experience
Highlight your previous experience in the Medical Device industry, particularly any specific projects or challenges you've faced. Use examples that illustrate your ability to manage Quality Events, CAPAs, and Change Controls effectively.
✨Prepare for Technical Questions
Expect technical questions related to Quality Management Systems and risk management activities. Brush up on your knowledge of generating and maintaining Design History Files and Technical Documentation, as these are crucial for the role.
✨Demonstrate Team Collaboration
Quality Assurance is often a team effort, so be ready to discuss how you work with cross-functional teams. Share examples of how you've supported compliance activities, audits, or employee training, showcasing your ability to collaborate and communicate effectively.
