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- Tasks: Conduct internal and supplier audits to ensure compliance with quality standards.
- Company: Join a fast-growing international medical device company focused on organ transplantation.
- Benefits: Enjoy hybrid work options with minimal travel and opportunities for professional growth.
- Why this job: Make a meaningful impact on life-saving technologies while collaborating with diverse teams.
- Qualifications: Bachelor’s degree in a relevant field and 3 years of auditing experience required.
- Other info: Proficiency in Microsoft Office and knowledge of regulatory standards is essential.
The predicted salary is between 36000 - 60000 £ per year.
A fast-growing, international medical device company committed to advancing organ transplantation and improving patient outcomes globally is seeking a Quality Auditor to strengthen their Quality Assurance team.
As a Quality Auditor, you will play a key role in conducting internal and supplier audits to ensure compliance with our Quality Management System (QMS), regulatory requirements, and industry best practices. You will be responsible for identifying areas of improvement, supporting continuous improvement initiatives, and helping ensure the safety and effectiveness of our products. This role requires significant collaboration across teams and suppliers and offers the opportunity to make a meaningful impact on the quality and reliability of life-saving medical technologies.
- Plan and execute internal audits and supplier audits per regulatory standards.
- Evaluate internal QMS processes and supplier systems for compliance and performance.
- Identify and support the implementation of corrective and preventive actions.
- Assist with supplier qualification, re-evaluation, and quality assessments.
- Participate in external audits and inspections by regulatory bodies or notified bodies.
- Collaborate closely with suppliers to drive quality improvements and compliance.
- Support training efforts internally.
Technical Tools: Proficiency in Microsoft Office (Excel, Word, PowerPoint, Visio, Access); Experience conducting quality system audits; Bachelor’s degree in a science, quality, regulatory, or related field (or equivalent experience).
Experience: Minimum 3 years of experience auditing within a medical device quality system or a similar regulated environment.
Regulatory Knowledge: In-depth understanding of FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDR 2017/745, and MDSAP; familiarity with upcoming regulatory changes is a plus.
Travel: Willingness and ability to travel 10–15%.
QA Auditor / Analyst employer: Skills Alliance
Contact Detail:
Skills Alliance Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Auditor / Analyst
✨Tip Number 1
Familiarise yourself with the specific regulatory standards mentioned in the job description, such as FDA 21 CFR Part 820 and ISO 13485. This knowledge will not only help you during interviews but also demonstrate your commitment to understanding the industry.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who work in quality assurance. Attend relevant conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in quality auditing.
✨Tip Number 3
Prepare to discuss your previous auditing experiences in detail, focusing on how you identified areas for improvement and implemented corrective actions. Use specific examples that highlight your problem-solving skills and ability to collaborate with teams.
✨Tip Number 4
Showcase your proficiency in Microsoft Office tools, particularly Excel and PowerPoint, as these are essential for reporting and presenting audit findings. Consider creating a sample report or presentation to demonstrate your skills during the interview process.
We think you need these skills to ace QA Auditor / Analyst
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Quality Auditor. Familiarise yourself with the key requirements such as conducting audits, compliance with QMS, and regulatory standards.
Tailor Your CV: Highlight your relevant experience in auditing within a medical device quality system. Emphasise your knowledge of regulatory standards like FDA 21 CFR Part 820 and ISO 13485, as well as any specific tools or methodologies you've used.
Craft a Compelling Cover Letter: In your cover letter, express your passion for quality assurance and how your background aligns with the company's mission to improve patient outcomes. Mention specific examples of how you've contributed to quality improvements in previous roles.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial for a Quality Auditor role.
How to prepare for a job interview at Skills Alliance
✨Know Your Regulations
Familiarise yourself with key regulations such as FDA 21 CFR Part 820 and ISO 13485. Being able to discuss these in detail will show your understanding of the industry standards and demonstrate your readiness for the role.
✨Showcase Your Audit Experience
Prepare specific examples from your past auditing experiences, especially within medical device quality systems. Highlight how you identified areas for improvement and implemented corrective actions, as this will illustrate your hands-on expertise.
✨Emphasise Collaboration Skills
Since the role involves significant collaboration with teams and suppliers, be ready to discuss how you've successfully worked with others in the past. Share examples that showcase your ability to drive quality improvements through teamwork.
✨Prepare Questions About Continuous Improvement
Think of insightful questions regarding the company's approach to continuous improvement initiatives. This shows your proactive mindset and genuine interest in contributing to the organisation's goals.
