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For Companies At a Glance
- 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 auditing experience and knowledge of medical device 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
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 your familiarity with relevant regulations like EU MDR and ISO 13485 during networking events. Engaging with professionals in the field can help you learn about unadvertised opportunities.
✨Tip Number 2
Consider joining industry-specific groups or forums where you can connect with other auditors and share insights. This can not only expand your network but also keep you updated on best practices and job openings.
✨Tip Number 3
If you have any certifications, such as being an IRCA registered auditor, make sure to mention them in conversations with industry contacts. This can set you apart from other candidates and demonstrate your commitment to professional standards.
✨Tip Number 4
Stay informed about the latest developments in medical device regulations and standards. Being knowledgeable about changes in the industry can give you an edge in discussions and interviews, showing that you are proactive and well-prepared.
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 a good fit for their team and how your skills align with their needs.
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 your knowledge 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 during audits. Discuss any instances where you detected noncompliance or fraud, and explain how you addressed these issues. This will showcase your analytical abilities and attention to detail.
✨Communicate Audit Findings Effectively
Practice explaining audit findings clearly and concisely. You may be asked how you would present your findings to an auditee. Focus on your ability to recommend solutions and communicate effectively, as this is crucial for a Lead Auditor role.
