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Senior Lead Auditor – In-vitro diagnostic medical devices

Posted 2024-11-15

View full description

💎 Seniority level: Senior, Minimum of 4 years

🔍 Industry: In-vitro diagnostic medical devices

🗣️ Languages: English

⏳ Experience: Minimum of 4 years

Requirements:
  • Previous auditing experience within an IVD or IVDR notified body is mandatory.
  • Minimum of 4 years’ hands-on professional experience in designing, manufacturing, or testing IVDs.
  • At least 2 years of this experience in quality assurance/quality management under a structured system.
  • University degree or equivalent in relevant sciences such as Chemistry, Biochemistry, Biology, etc.
  • Knowledge of EU IVDR 2017/746 and relevant standards and guidance documents.
  • Experience in planning and prioritizing workloads, willingness to travel internationally.
  • Good English written and verbal skills.
Responsibilities:
  • Support the development of the global SGS medical device auditor network.
  • Aid in the qualification of trainee auditors through witnessing audits and feedback.
  • Act as a key point of contact for SGS medical device offices and mentor junior colleagues.
  • Contribute to process improvements for IVDR conformity assessment.
  • Conduct audits at client sites and remotely, ensuring customer satisfaction and compliance.
  • Manage chargeable work within budget and timeframes.
  • Complete specific projects as requested by the Medical Devices Manager.
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🔥 Senior Lead Auditor – In-vitro diagnostic medical devices
Posted 2024-11-15

🔍 In-vitro diagnostic medical devices

  • Previous auditing experience within an IVD or IVDR notified body is mandatory.
  • A minimum of 4 years 'hands-on' professional experience in designing, manufacturing, or testing of IVDs.
  • At least 2 years should be in quality assurance/management under a structured quality management system.
  • A university degree in relevant sciences such as Chemistry, Biochemistry, Biology, etc.
  • Knowledge of EU IVDR 2017/746 and relevant standards for in-vitro diagnostic medical devices.

  • Support the development of the global SGS medical device auditor network by aiding the qualification of trainee auditors.
  • Act as a key point of contact for the SGS medical device offices and mentor junior colleagues.
  • Contribute to the continuous improvement of processes and tools for IVDR conformity assessment.
  • Conduct audits at clients' sites and remotely, ensuring effective customer relationships.
  • Complete all chargeable work within budget and timeframes for customer satisfaction.
Posted 2024-11-15
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🔥 Senior Lead Auditor – In-vitro diagnostic medical devices
Posted 2024-11-14

🔍 In-vitro diagnostic medical devices

  • Previous auditing experience within an IVD or IVDR notified body is mandatory.
  • Minimum of 4 years 'hands-on' professional experience in designing, manufacturing or testing IVDs.
  • At least 2 years of experience in quality assurance/management within a structured quality management system.
  • A university degree or equivalent in relevant sciences such as Chemistry, Biology, Biomedical Engineering, etc.

  • Support the development of the global SGS medical device auditor network by aiding the qualification of trainee auditors.
  • Conduct audits at clients’ sites and remotely, maintaining high standards of service delivery.
  • Act as a key point of contact for SGS medical device offices and mentor junior colleagues.
  • Complete all chargeable work within budget and timeframes to ensure customer satisfaction.
  • Contribute to continuous improvement of processes and tools used for IVDR conformity assessment.
Posted 2024-11-14
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Apply
🔥 Senior Lead Auditor – In-vitro diagnostic medical devices
Posted 2024-11-14

🔍 In-vitro diagnostic medical devices

  • Previous auditing experience within an IVD or IVDR notified body is mandatory.
  • A minimum of 4 years ‘hands-on’ professional experience in designing, manufacturing, or testing of IVDs.
  • At least 2 years of experience in quality assurance/quality management under a structured system.
  • A relevant university degree or equivalent qualification in sciences such as Chemistry, Biology, or Engineering.

  • Support the development of the global SGS medical device auditor network by aiding the qualification of trainee auditors.
  • Act as a key point of contact for the SGS medical device offices and mentor junior colleagues.
  • Contribute to the continuous improvement of processes and tools for IVDR conformity assessment.
  • Conduct audits at clients’ sites and remotely, maintaining service delivery standards.
  • Complete all chargeable work within required budgets and timeframes.
Posted 2024-11-14
Apply

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