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- Tasks: Assess in-vitro diagnostic medical devices for compliance with European laws.
- Company: Join SGS, a global leader in inspection and certification services.
- Benefits: Enjoy a culture that values innovation and personal growth.
- Why this job: Make an impact in healthcare while developing your auditing skills.
- Qualifications: A keen interest in medical devices and attention to detail is essential.
- Other info: Be part of a team that encourages new ideas and challenges the norm.
The predicted salary is between 36000 - 60000 £ per year.
Company Description We are delighted that you’re thinking about a career with SGS! We currently have an exciting opportunity at SGS for an In-vitro diagnostic Medical Device Auditor to join our highly successful certification division in the South Region. SGS are the global leader and innovator in inspection, verification, testing and certification services. Trusted all over the world, SGS is a market leader because we put 100% passion, pride and innovation into everything we do. We encourage new ideas. We welcome people who challenge the way we do things. And we will be 100% committed to helping you reach your full potential. Job Description Your role will be to assess in-vitro diagnostic medical devices for strict compliance with the relevant European laws ( EU IVDR; Regulation 2017/746 ). You key task will be carrying out reviews of the manufacturers’ technical documentation as part of the CE marking process. This will require a keen interest in and deep understanding of the product technologies being assessed, knowledge of the clinical application of the devices, as well as a keen eye for detail. The successful candidate will be responsible for planning and conducting audits of medical devices to EU MDD 93/42/EEC, EU MDR 2017/745, Directive 93/43/EEC equivalent to UK MDR 2002 as amended for UKCA, ISO 13485 and MDSAP…
IVD Medical Device Lead Auditor employer: SGS UK Limited
Contact Detail:
SGS UK Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land IVD Medical Device Lead Auditor
✨Tip Number 1
Familiarize yourself with the latest regulations and standards related to in-vitro diagnostic medical devices, especially the EU IVDR and ISO 13485. This knowledge will not only help you during the interview but also demonstrate your commitment to staying updated in this rapidly evolving field.
✨Tip Number 2
Network with professionals in the medical device auditing field. Attend relevant conferences or webinars where you can meet current auditors and learn about their experiences. This can provide you with valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare for the interview by practicing common audit scenarios and questions related to compliance assessments. Being able to articulate your thought process and decision-making skills in these situations will set you apart from other candidates.
✨Tip Number 4
Showcase your attention to detail by discussing specific examples from your past experience where you identified compliance issues or improved processes. This will highlight your suitability for the role and align with SGS's commitment to quality and innovation.
We think you need these skills to ace IVD Medical Device Lead Auditor
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the IVD Medical Device Lead Auditor position. Understand the key responsibilities and required qualifications, especially regarding compliance with European laws and technical documentation.
Highlight Relevant Experience: In your CV and cover letter, emphasize any previous experience you have in auditing medical devices or working with in-vitro diagnostics. Be specific about your familiarity with EU regulations and standards like ISO 13485.
Showcase Your Skills: Demonstrate your keen eye for detail and analytical skills in your application. Provide examples of how you've successfully conducted audits or assessments in the past, particularly in relation to medical devices.
Tailor Your Application: Customize your cover letter to reflect your passion for the role and the company. Mention why you are excited about the opportunity at SGS and how your values align with their commitment to innovation and quality.
How to prepare for a job interview at SGS UK Limited
✨Understand the Regulations
Make sure you have a solid grasp of the relevant European laws, especially the EU IVDR and EU MDR. Be prepared to discuss how these regulations impact the auditing process and demonstrate your knowledge of compliance requirements.
✨Showcase Your Technical Knowledge
Highlight your understanding of in-vitro diagnostic medical devices and their clinical applications. Be ready to discuss specific technologies and how they relate to the auditing process, as this will show your expertise in the field.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think about past experiences where you had to conduct audits or reviews, and be ready to explain your approach and the outcomes.
✨Demonstrate Attention to Detail
Since the role requires a keen eye for detail, prepare examples that showcase your meticulousness in previous roles. Discuss how you ensure accuracy in documentation and compliance checks during audits.
