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- Tasks: Lead audits for medical devices, ensuring compliance with EU and UK regulations.
- Company: Join TUV Rheinland UK, a leader in safety and quality assurance.
- Benefits: Enjoy opportunities for travel and professional growth in a dynamic environment.
- Why this job: Make a real impact in healthcare by ensuring device safety and compliance.
- Qualifications: 2 years of experience in medical device auditing and knowledge of relevant regulations required.
- Other info: Must have a full UK driving license and be ready for significant travel.
The predicted salary is between 36000 - 60000 £ per year.
Job Summary Is this the next step in your career Find out if you are the right candidate by reading through the complete overview below. TUV Rheinland UK is looking for a Lead Auditor, responsible for planning and conducting medical device audits in compliance with EU and UK Regulations/Legislation. Job Description Plans, prepares and carries out audits in compliance with EU MDR, EU IVDR, UK MDR, MDSAP, and ISO 13485. Coordinates the schedule and audit plan with the customer and, if necessary, with the auditor team Collects and analyses data to detect deficient controls, duplicated effort, fraud or noncompliance with laws, regulations, and management policies. Might lead the audit in the function of the lead auditor. Records strengths, deviations, recommendations and evidence viewed. Creates audit documentation and audit reports. Prepares explains audit findings and recommends solutions to auditee. And other duties as assigned. Essential Requirements: 2 years’ experience as medical device auditor 2 years’ experience in Design, Manufacturing, or Testing of Medical Devices Ideally registered IRCA auditor or equivalent recognition with a recognised body Knowledge of UK MDR 2002 Knowledge of ISO 13485 Knowledge of EU MDD 93/42/EC, EU MDR 2017/745 Significant UK travel with limited international travel Full UK Driving Licence
Lead Auditor employer: TÜV Rheinland Europe
Contact Detail:
TÜV Rheinland Europe Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Lead Auditor
✨Tip Number 1
Make sure to highlight your experience in medical device auditing and any specific regulations you are familiar with, such as EU MDR or ISO 13485. This will show us that you have the relevant background for the Lead Auditor role.
✨Tip Number 2
If you have led audits before, be prepared to discuss your leadership style and how you coordinate with teams. We value strong leadership skills, especially in a role where you might lead audit teams.
✨Tip Number 3
Familiarize yourself with the latest updates in UK and EU regulations regarding medical devices. Showing us that you are up-to-date with current legislation can set you apart from other candidates.
✨Tip Number 4
Be ready to provide examples of how you've identified and resolved compliance issues in past roles. We appreciate candidates who can demonstrate their problem-solving abilities in real-world scenarios.
We think you need these skills to ace Lead Auditor
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Lead Auditor position at TUV Rheinland UK. Understand the key responsibilities and essential requirements, especially regarding medical device audits and relevant regulations.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience as a medical device auditor and any relevant roles in design, manufacturing, or testing of medical devices. Be specific about your achievements and how they relate to the job.
Showcase Your Knowledge: Demonstrate your knowledge of UK MDR, ISO 13485, and EU regulations in your application. Mention any certifications, such as being an IRCA registered auditor, to strengthen your candidacy.
Tailor Your Application: Customize your cover letter to reflect your understanding of TUV Rheinland UK's mission and values. Explain why you are interested in this role and how you can contribute to their team.
How to prepare for a job interview at TÜV Rheinland Europe
✨Show Your Expertise in Medical Device Auditing
Make sure to highlight your experience as a medical device auditor. Discuss specific audits you've conducted and the regulations you've worked with, such as EU MDR and ISO 13485. This will demonstrate your knowledge and suitability for the role.
✨Prepare for Technical Questions
Expect questions related to the technical aspects of medical device regulations. Brush up on the key points of UK MDR 2002 and EU MDD 93/42/EC. Being able to discuss these topics confidently will show that you are well-prepared and knowledgeable.
✨Demonstrate Strong Analytical Skills
Be ready to provide examples of how you've collected and analyzed data in previous audits. Discuss any instances where you detected noncompliance or inefficiencies, and explain how you addressed these issues. This will showcase your problem-solving abilities.
✨Communicate Audit Findings Effectively
Practice explaining complex audit findings in a clear and concise manner. You may be asked how you would present your findings to an auditee, so think about how you can make your recommendations actionable and understandable.
