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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.
- 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
Familiarise yourself with ISO 13485 and other relevant regulations. Understanding these standards inside out 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 Quality Assurance field, especially those who work in the medical device sector. Attend industry events or join online forums to connect with others and gain insights that could give you an edge during the hiring process.
✨Tip Number 3
Prepare to discuss specific examples of how you've handled Quality Events, CAPAs, or Change Controls in your previous roles. Being able to articulate your experience with real-life scenarios will showcase your expertise and problem-solving skills.
✨Tip Number 4
Research the company’s recent projects and innovations in ear and hearing healthcare. Showing genuine interest and knowledge about their work can set you apart and demonstrate that you're not just looking for any job, but are specifically excited about this opportunity.
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 compliance with regulatory requirements.
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, as these are crucial for this role.
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, particularly in relation to audits and compliance activities.
Craft a Compelling Cover Letter: Write a tailored cover letter that connects your skills and experiences to the specific needs of the company. Express your enthusiasm for the role and the innovative work being done in ear and hearing healthcare, making it clear why you're a great fit for their team.
How to prepare for a job interview at Cure Talent
✨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 your experience aligns with these standards and how you can contribute to maintaining compliance.
✨Showcase Your Experience
Highlight your previous roles in Quality Assurance, especially within the Medical Device industry. Be ready to provide specific examples of how you've handled Quality Events, CAPAs, and Change Controls in past positions.
✨Prepare for Technical Questions
Expect technical questions related to Quality Management Systems and risk management activities. Brush up on your knowledge of generating SOPs and maintaining Design History Files, as these are crucial for the role.
✨Demonstrate Team Collaboration
Quality Assurance is often a team effort. Be prepared to discuss how you've worked with cross-functional teams in the past, particularly in supporting audits and training employees on compliance matters.
