At a Glance
- 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.
- Other info: Ideal for those passionate about quality assurance and regulatory compliance.
- 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.
The predicted salary is between 36000 - 60000 £ per year.
Company Overview
We are delighted to be partnered with a growing healthcare technology company focused on improving ear and hearing health. Its integrated platform supports ear and hearing assessment, diagnosis and treatment within a single appointment, complemented by a training programme that helps practitioners deliver confident, effective care. As the business continues to expand, it is seeking a QA Specialist to join its team on a six-month fixed-term contract, based in London with hybrid working.
Position Overview
The QA Specialist will support the development and continuous improvement of quality and regulatory processes across software and hardware-related products. The role will help strengthen the quality management system, improve process consistency and support faster, more effective decision-making as the organisation scales.
Working cross-functionally, the successful candidate will manage and improve quality activities including document control, SOPs, nonconformances, CAPA, change control and internal audits. They will also review existing processes, identify opportunities for improvement, maintain quality records and contribute to technical documentation. This is an opportunity to make a visible contribution within a collaborative, fast-paced healthcare technology environment.
In practice, the team is looking for someone who can provide hands-on support to help close existing quality gaps, reduce the backlog of open findings and improve delivery speed. Experience working with legacy technology, an evolving QMS setup such as Qualia or a comparable system, and a pragmatic approach to quicker decision-making would all be valuable.
About the Ideal Candidate
The ideal candidate will be a pragmatic and detail-oriented quality professional with experience in medical devices or medical technology. They will be confident supporting regulated software and hardware products, improving quality systems and collaborating across teams. Strong organisation, communication skills and a systematic approach will be important.
Role Responsibilities
- Support the maintenance and continuous improvement of the quality management system, including the optimisation of workflows and quality processes.
- Review existing processes to identify gaps, inefficiencies and practical opportunities for improvement.
- Govern quality activities including nonconformances, CAPA, change control, internal audits and quality metrics.
- Generate, review and revise SOPs, technical documentation and associated quality records.
- Work cross-functionally to support compliance across software and hardware products, embedding consistent and sustainable quality practices as the business grows.
Key Requirements / What We Look For
- Experience in quality assurance, quality operations or quality systems within medical devices or medical technology.
- Working knowledge of ISO 13485, EU MDR, FDA QSR / 21 CFR Part 820 and EN 62304.
- Experience with QMS processes, document control, SOPs, nonconformances, CAPA, change control and in... internal audits.
- Experience supporting regulated software and hardware products.
- Strong organisation, attention to detail, communication skills and a pragmatic approach …
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Quality Assurance Specialist employer: Cure Talent Ltd
Cure Talent Ltd offers an exceptional work environment for the MedTech B2B Sales Executive role, where employees are empowered to drive innovation in healthcare delivery. With a strong focus on professional development and a culture that values collaboration and creativity, team members enjoy uncapped commission opportunities and the chance to make a meaningful impact in the healthcare sector across the UK.
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.
