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- Tasks: Conduct internal audits to ensure compliance with quality standards and regulations.
- Company: Join a dynamic global medical device organisation focused on quality and innovation.
- Benefits: Enjoy a permanent full-time role with opportunities for professional growth and development.
- Why this job: Be part of a team that drives quality improvements and impacts healthcare positively.
- Qualifications: University degree in a relevant field and 3 years of experience in medical device auditing required.
- Other info: Ideal for detail-oriented individuals passionate about quality management systems.
The predicted salary is between 36000 - 60000 £ per year.
As part of its continued growth, a dynamic and global medical device organization are seeking a meticulous and organized Internal Auditor – QMS to join its team. The Internal Auditor – QMS is responsible for conducting internal audits across global sites to ensure compliance with company policies, quality standards, and applicable regulations. The ideal candidate will possess excellent attention to detail, strong organizational abilities, and a background in conducting thorough, value-added audits that support ongoing quality system improvements. This role is vital for ensuring that company operations align with the Quality Management System (QMS).
- Conduct internal audits to ensure compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR, and other applicable standards.
- Evaluate organizational processes against defined quality standards.
- Perform risk assessments and analyze audit outcomes to detect trends or systemic issues.
- Prepare and present detailed audit reports to management.
- Support development and implementation of corrective action plans based on audit findings.
- Provide training and guidance to staff regarding quality standards and QMS principles.
- Stay informed on the latest developments in relevant quality standards and regulations.
- Comply with the company’s Code of Conduct and all other corporate policies.
Qualifications:
- University or college degree, preferably in a scientific or quality/regulatory discipline.
- Minimum of 3 years of experience in medical device quality auditing, or a comparable combination of education and experience.
- In-depth knowledge of medical device regulations including FDA QSR, ISO 13485, ISO 14971, EU MDR, MDSAP, and CMDR.
- High emotional intelligence and professional demeanor to ensure positive engagement with auditees during audits.
- Proficiency in Microsoft Office tools (Excel, PowerPoint, Visio, Word, Access).
- Experience in quality audits preferred; lead auditor certification in ISO 13485, MDR, or MDSAP is an asset.
Auditor / Internal Auditor employer: Skills Alliance
Contact Detail:
Skills Alliance Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Auditor / Internal Auditor
✨Tip Number 1
Familiarise yourself with the specific regulations and standards mentioned in the job description, such as FDA 21 CFR Part 820 and ISO 13485. This knowledge will not only help you during the interview but also demonstrate your commitment to understanding the role.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who have experience in quality auditing. Engaging with them can provide insights into the company culture and expectations, which can be invaluable during your application process.
✨Tip Number 3
Prepare to discuss your previous auditing experiences in detail, focusing on how you added value through your audits. Be ready to share specific examples of how your work led to improvements in quality systems or compliance.
✨Tip Number 4
Stay updated on the latest trends and changes in quality management systems and regulations. Showing that you are proactive about your professional development can set you apart from other candidates.
We think you need these skills to ace Auditor / Internal Auditor
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in medical device quality auditing. Emphasise your knowledge of FDA regulations, ISO standards, and any lead auditor certifications you hold.
Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Mention specific experiences that demonstrate your attention to detail and organisational skills, as well as your ability to conduct thorough audits.
Showcase Relevant Skills: Highlight your proficiency in Microsoft Office tools, especially Excel and PowerPoint, as these will be crucial for preparing audit reports and presentations. Include examples of how you've used these tools in past roles.
Prepare for Potential Questions: Think about how you would respond to questions regarding your experience with quality management systems and regulatory compliance. Be ready to discuss specific audits you've conducted and the outcomes.
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, ISO 13485, and EU MDR. Being able to discuss these standards confidently will demonstrate your expertise and show that you are well-prepared for the role.
✨Showcase Your Audit Experience
Prepare specific examples from your past auditing experiences that highlight your attention to detail and ability to conduct thorough audits. Discuss how your findings led to improvements in quality systems, as this will illustrate your value to the organisation.
✨Emphasise Soft Skills
Highlight your emotional intelligence and professional demeanour during the interview. The ability to engage positively with auditees is crucial, so be ready to share examples of how you've successfully navigated challenging conversations in the past.
✨Prepare Questions
Have insightful questions ready about the company's quality management practices and future goals. This shows your genuine interest in the role and helps you assess if the company aligns with your career aspirations.
