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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 compliance.
- Benefits: Enjoy a permanent full-time role with opportunities for professional growth.
- Why this job: Be part of a vital team ensuring quality in healthcare, making a real impact.
- Qualifications: Degree in a scientific or quality discipline; 3 years of relevant auditing experience 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.
Internal Auditor (Regulatory) employer: Skills Alliance
Contact Detail:
Skills Alliance Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Internal Auditor (Regulatory)
✨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 management systems. 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 regulations. Showing that you are proactive about your professional development can set you apart from other candidates and demonstrate your dedication to the field.
We think you need these skills to ace Internal Auditor (Regulatory)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in medical device quality auditing and compliance with standards like FDA QSR and ISO 13485. Use specific examples to demonstrate your attention to detail and organizational skills.
Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Mention your understanding of the Quality Management System (QMS) and how your background aligns with the responsibilities of the Internal Auditor position.
Highlight Relevant Skills: Emphasise your proficiency in Microsoft Office tools and any lead auditor certifications you hold. Discuss your experience in conducting audits and preparing detailed reports, as these are crucial for the role.
Showcase Continuous Learning: Mention any recent training or courses you've completed related to quality standards and regulations. This demonstrates your commitment to staying informed and improving your skills in the field.
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. Be prepared to discuss how these standards apply to the role and share examples of how you've ensured compliance in previous positions.
✨Demonstrate Attention to Detail
As an Internal Auditor, attention to detail is crucial. During the interview, highlight specific instances where your meticulous nature has led to successful audits or improvements in quality management systems.
✨Showcase Your Audit Experience
Be ready to talk about your past auditing experiences, particularly in the medical device sector. Discuss the types of audits you've conducted, the challenges you faced, and how you overcame them to add value to the organisation.
✨Engage with Emotional Intelligence
Since the role involves interacting with various stakeholders, demonstrate your emotional intelligence. Share examples of how you've effectively communicated with auditees and managed relationships during audits to foster a positive environment.
