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- Tasks: Lead audits for in-vitro diagnostic medical devices and ensure compliance with industry standards.
- Company: Join a dynamic team focused on improving healthcare through innovative medical device auditing.
- Benefits: Enjoy a field-based role with travel across the UK, plus a company car or allowance.
- Why this job: Make a real impact in healthcare while developing your skills in a supportive environment.
- Qualifications: Degree in a relevant scientific field and experience in IVDs or Quality Management Systems required.
- Other info: Opportunity to work independently or lead teams, fostering strong client relationships.
The predicted salary is between 36000 - 60000 £ per year.
Job Description
Job Title: IVD Lead Auditor \\nLocation: Field-based (UK)\\nTravel: Primarily within the UK (Company car or car allowance provided)\\n\\nOur 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).\\nKey Responsibilities:\\n•\\tConduct on-site audits for clients using established procedures, delivering high-quality service that fosters strong customer relationships.\\n•\\tWork independently or lead audit teams, ensuring customer satisfaction and compliance with industry standards and regulatory requirements.\\n•\\tComplete all audits and tasks within the set budget and time constraints.\\n•\\tUndertake specific projects related to medical device processes, systems, documentation, and procedures, as assigned by the Medical Devices Manager.\\nQualifications:\\n•\\tPractical experience in the design, manufacturing, or testing of IVD medical devices, with experience in Quality Management System (QMS) or in Quality Management/Regulatory Affairs.\\n•\\tA 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.\\n•\\tFamiliarity with IVDs and Medical Devices (active, non-active, or software-based) and Medical Device Quality Management Systems.\\n•\\tIn-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.\\n•\\tUnderstanding of relevant IVD and Medical Device Standards
IVD Lead Auditor employer: Kenton Black
Contact Detail:
Kenton Black Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land IVD Lead Auditor
✨Tip Number 1
Make sure to familiarize yourself with the specific regulations and standards mentioned in the job description, such as the EU IVDR and ISO 13485. This knowledge will not only help you during the interview but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the IVD and medical device industry. Attend relevant conferences or webinars to connect with potential colleagues and learn more about current trends and challenges in the field.
✨Tip Number 3
Prepare for the possibility of leading audit teams by brushing up on your leadership and communication skills. Being able to effectively manage a team and communicate findings is crucial for this role.
✨Tip Number 4
Research the company’s values and mission. Understanding their approach to quality management and customer satisfaction can give you an edge in interviews and help you align your answers with their expectations.
We think you need these skills to ace IVD Lead Auditor
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the IVD Lead Auditor position. Understand the key responsibilities and qualifications required, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasize your practical experience in the design, manufacturing, or testing of IVD medical devices. Mention any specific projects or roles that align with the responsibilities outlined in the job description.
Showcase Your Knowledge: Demonstrate your understanding of relevant regulations and standards such as EU IVDR, ISO 13485, and other directives mentioned in the job description. This can set you apart from other candidates.
Craft a Strong Cover Letter: Write a compelling cover letter that not only summarizes your qualifications but also expresses your enthusiasm for the role. Make sure to connect your skills and experiences directly to the needs of the company.
How to prepare for a job interview at Kenton Black
✨Know Your Regulations
Make sure you have a solid understanding of the EU IVDR and other relevant regulations. Be prepared to discuss how these regulations impact the auditing process and your previous experiences with compliance.
✨Demonstrate Your Audit Experience
Highlight your practical experience in conducting audits, especially in the context of IVD medical devices. Share specific examples of audits you've led or participated in, focusing on the outcomes and customer satisfaction.
✨Showcase Your Technical Knowledge
Be ready to discuss your educational background and how it relates to the role. Emphasize your familiarity with Quality Management Systems and any specific standards like ISO 13485 that are relevant to the position.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills and ability to work under pressure. Think about past challenges you've faced in audits and how you resolved them while maintaining compliance and quality.
