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- Tasks: Conduct audits of in-vitro diagnostic medical devices and ensure compliance with industry standards.
- Company: Join a leading company in the medical device sector, dedicated to quality and innovation.
- Benefits: Enjoy a company car or allowance, flexible working conditions, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare while developing your skills in a dynamic environment.
- Qualifications: Degree in a relevant scientific field and experience in IVDs or Quality Management Systems required.
- Other info: Field-based role with travel across the UK; perfect for those who love variety in their work.
The predicted salary is between 36000 - 60000 £ per year.
Location: Field-based (UK)
Travel: Primarily within the UK (Company car or car allowance provided)
Our client is looking to recruit an Invitro Diagnostics Lead Auditor to plan and conduct audits of in-vitro diagnostic medical devices to EU IVDR (EU Regulation 2017/746).
Key Responsibilities:
- Conduct on-site audits for clients using established procedures, delivering high-quality service that fosters strong customer relationships.
- Work independently or lead audit teams, ensuring customer satisfaction and compliance with industry standards and regulatory requirements.
- Complete all audits and tasks within the set budget and time constraints.
- Undertake specific projects related to medical device processes, systems, documentation, and procedures, as assigned by the Medical Devices Manager.
Qualifications:
- Practical experience in the design, manufacturing, or testing of IVD medical devices, with experience in Quality Management System (QMS) or in Quality Management/Regulatory Affairs.
- A university degree or equivalent qualification in a relevant scientific field, such as: Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Physics, Biophysics, Material Science, Biomedical Engineering, Mechanical, Electrical, or Electronic Engineering, or Computer & Software Technology.
- Familiarity with IVDs and Medical Devices (active, non-active, or software-based) and Medical Device Quality Management Systems.
- In-depth knowledge of EU IVD Directive 98/79/EC, EU IVD Regulation 2017/746, EU Medical Device Directive 93/42/EEC, EU Medical Device Regulation 2017/745, UK Medical Device Regulation, and ISO 13485.
- Understanding of relevant IVD and Medical Device Standards.
Contact Detail:
Kenton Black Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land IVD Lead Auditor
✨Tip Number 1
Familiarise yourself with the latest EU IVDR regulations and standards. Being well-versed in these will not only boost your confidence during interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the IVD and medical device sectors. Attend relevant conferences or webinars, and connect with industry experts on platforms like LinkedIn to gain insights and potentially get referrals.
✨Tip Number 3
Prepare for practical scenarios that may be discussed during the interview. Think about past experiences where you successfully conducted audits or managed compliance issues, as these examples can showcase your expertise.
✨Tip Number 4
Research our company culture and values at StudySmarter. Understanding what we stand for will help you align your answers with our mission, making you a more attractive candidate for the role.
We think you need these skills to ace IVD Lead Auditor
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the IVD Lead Auditor position. Familiarise yourself with the relevant regulations and standards mentioned in the job description.
Tailor Your CV: Customise your CV to highlight your experience in the design, manufacturing, or testing of IVD medical devices. Emphasise any relevant qualifications and practical experience in Quality Management Systems or Regulatory Affairs.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the role and the industry. Mention specific experiences that demonstrate your ability to conduct audits and ensure compliance with industry standards.
Highlight Relevant Skills: In your application, be sure to highlight skills that are particularly relevant to the role, such as your knowledge of EU regulations, familiarity with IVDs, and experience with audit processes. Use specific examples to illustrate your expertise.
How to prepare for a job interview at Kenton Black Ltd
✨Know Your Regulations
Familiarise yourself with the EU IVDR and other relevant regulations before the interview. Being able to discuss these in detail will demonstrate your expertise and show that you are serious about the role.
✨Showcase Your Experience
Prepare specific examples from your past work that highlight your experience in auditing IVD medical devices. Discuss how you've ensured compliance and customer satisfaction in previous roles.
✨Demonstrate Leadership Skills
If you've led audit teams before, be ready to share your leadership style and how you manage team dynamics. This is crucial as the role may require you to lead audits independently or with a team.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to audits and their expectations for the role. This shows your interest in the position and helps you assess if it's the right fit for you.
