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- Tasks: Conduct internal and supplier audits to ensure compliance with quality standards.
- Company: Join a fast-growing medical device company focused on improving organ transplantation globally.
- 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: Lead auditor certification preferred; stay updated on evolving regulations.
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.
Key Responsibilities:- Plan and execute internal audits and supplier audits per regulatory standards (e.g., ISO 13485:2016, FDA 21 CFR Part 820, EU MDR).
- Maintain and deliver audit schedules, ensuring timely execution and reporting.
- Evaluate internal QMS processes and supplier systems for compliance and performance.
- Identify and support the implementation of corrective and preventive actions.
- Generate audit reports, communicate findings to stakeholders, and track resolution effectiveness.
- Assist with supplier qualification, re-evaluation, and quality assessments.
- Participate in external audits and inspections (e.g., by regulatory bodies or notified bodies).
- Collaborate closely with suppliers to drive quality improvements and compliance.
- Stay informed of evolving regulations and standards; support training efforts internally.
- Interpersonal & Communication: Able to foster respectful, collaborative relationships with audit stakeholders; able to clearly communicate audit findings and facilitate open dialogue.
- Critical Thinking: Strong analytical skills and a proactive approach to identifying improvement opportunities beyond basic compliance.
- Technical Tools: Proficiency in Microsoft Office (Excel, Word, PowerPoint, Visio, Access); experience with QMS platforms such as MasterControl is a plus.
- Organizational Abilities: Highly organized, detail-oriented, and capable of managing multiple priorities effectively.
- Audit Expertise: Experience conducting quality system audits; lead auditor certification (ISO 13485, MDR, MDSAP) preferred.
- Education: 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.
- Communication: Strong written and verbal skills; comfortable engaging with diverse teams and external partners.
- Travel: Willingness and ability to travel 10–15%.
Quality Auditor employer: Skills Alliance
Contact Detail:
Skills Alliance Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Auditor
✨Tip Number 1
Familiarise yourself with the specific regulatory standards mentioned in the job description, such as ISO 13485 and FDA 21 CFR Part 820. This knowledge will not only help you during interviews but also demonstrate your commitment to understanding the role's requirements.
✨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 specific examples of audits you've conducted in the past, focusing on how you identified areas for improvement and implemented corrective actions. This will showcase your practical experience and problem-solving skills.
✨Tip Number 4
Stay updated on the latest trends and changes in quality management systems and regulations within the medical device sector. Being knowledgeable about current events can help you stand out as a candidate who is proactive and engaged in the field.
We think you need these skills to ace Quality Auditor
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality auditing, particularly within the medical device sector. Emphasise your familiarity with regulatory standards like ISO 13485 and FDA regulations.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance and your understanding of the company's mission. Mention specific experiences where you've successfully conducted audits or implemented improvements.
Highlight Relevant Skills: In your application, clearly outline your interpersonal and communication skills, as well as your critical thinking abilities. Provide examples of how you've fostered collaboration and driven quality improvements in past roles.
Showcase Continuous Learning: Mention any ongoing education or certifications related to quality management systems or auditing. This demonstrates your commitment to staying updated with industry standards and regulations.
How to prepare for a job interview at Skills Alliance
✨Know Your Regulations
Familiarise yourself with key regulations such as ISO 13485 and FDA 21 CFR Part 820. Be prepared to discuss how these standards apply to quality auditing and how you have implemented them in past roles.
✨Showcase Your Audit Experience
Highlight your previous experience conducting audits, especially in the medical device sector. Be ready to share specific examples of audits you've led, challenges faced, and how you ensured compliance and improvement.
✨Demonstrate Strong Communication Skills
As a Quality Auditor, you'll need to communicate findings effectively. Practice articulating complex audit results clearly and concisely, and be prepared to discuss how you foster collaboration with stakeholders.
✨Prepare for Scenario-Based Questions
Expect questions that assess your critical thinking and problem-solving skills. Prepare to discuss hypothetical scenarios related to quality issues and how you would approach resolving them while ensuring compliance.
