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Senior Lead Auditor – In-vitro diagnostic medical devices

Posted 2024-11-14

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💎 Seniority level: Senior, Minimum 4 years

🔍 Industry: In-vitro diagnostic medical devices

🗣️ Languages: English

⏳ Experience: Minimum 4 years

Requirements:
  • Previous auditing experience in an IVD or IVDR notified body is mandatory.
  • A minimum of 4 years 'hands-on' professional experience in design, manufacturing, or testing of IVDs.
  • At least 2 years of experience in quality assurance/management under a structured quality management system.
  • University degree or equivalent in relevant sciences such as Chemistry, Biology, or Biomedical Engineering.
  • Knowledge of EU IVDR 2017/746 and relevant standards for in-vitro diagnostic medical devices.
Responsibilities:
  • Support the development of the global SGS medical device auditor network by aiding the qualification of trainee auditors.
  • Act as a mentor for junior colleagues and coordinate the expansion of the IVDR auditor network.
  • Contribute to continuous improvement of processes and tools for IVDR conformity assessment.
  • Conduct audits at client sites and remotely, maintaining high standards of service delivery.
  • Lead audit teams or work independently to enhance client satisfaction and ensure regulatory compliance.
  • Complete chargeable work within budget and timelines, and engage in specific projects related to medical devices as requested.
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🔥 Senior Lead Auditor – In-vitro diagnostic medical devices
Posted 2024-11-15

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  • Previous auditing experience within an IVD or IVDR notified body is mandatory.
  • A minimum of 4 years of hands-on professional experience in designing, manufacturing or testing of IVDs.
  • At least 2 years of this experience in quality assurance/management under a structured quality management system.
  • A university degree or equivalent in relevant sciences (Chemistry, Biology, etc.).
  • Knowledge of EU IVDR 2017/746 and relevant standards for in-vitro diagnostic medical devices.
  • Experience in planning and prioritizing workloads and willingness to travel internationally.

  • Support the development of the global SGS medical device auditor network by aiding the qualification of trainee auditors.
  • Witness qualification audits and provide feedback on trainee performance.
  • Act as a key point of contact and mentor for junior colleagues.
  • Contribute to continuous improvement of IVDR conformity assessment processes.
  • Conduct audits at client sites and maintain high service delivery standards.
  • Complete chargeable work within the required budget and timeframes.
  • Manage specific projects related to medical device procedures, processes, systems, and documentation.
Posted 2024-11-15
Apply
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 should be in quality assurance/quality management under a structured system.
  • A university degree or equivalent in relevant 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 SGS medical device offices and mentor junior colleagues.
  • Contribute to continuous improvement of processes for IVDR conformity assessment.
  • Conduct audits at clients’ sites and remotely, maintaining service delivery standards.
  • Complete all chargeable work within budget and timeframes to ensure customer satisfaction.
Posted 2024-11-14
Apply

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