Medical Device Auditor

5 giorni fa


Milano, Lombardia, Italia Luminary Group A tempo pieno

Luminary Group is seeking a meticulous and detail-oriented professional to join its team as a Medical Device Auditor. This role involves delivering high-quality audit services, ensuring compliance with applicable standards and regulations, and contributing to the continuous improvement of audits and internal controls within the organization.

Key Responsibilities:
  • Plan, execute, and lead audit engagements across various business units while ensuring adherence to established audit standards and methodologies.
  • Identify and assess risks, develop audit plans, and execute fieldwork to evaluate the effectiveness of internal controls.
  • Prepare and present clear, concise, and actionable audit reports to management, highlighting key findings and recommendations.
  • Work closely with cross-functional teams to understand business processes and identify areas for process improvement.
  • Monitor the implementation status of audit recommendations and follow up with management on audit findings.
  • Provide guidance and mentorship to junior auditors, fostering professional growth and knowledge sharing.
  • Stay current on industry trends and best practices to ensure audit methodologies are up-to-date.
  • Assist in special projects and other responsibilities as needed, contributing to the overall success of the audit function.

Requirements

  • Requirements
    • Coming from another institution or CTF (technical director) in pharmaceutical companies that also operate in the medical device sector
    • Degree in Chemistry, Pharmacy, Biology or equivalent
    • 3-5 years of experience in the pharmaceutical field and later in the medical device field or 3-5 years of experience in the medical device field containing substances
    • Knowledge of industry standards and laws
    • Technical knowledge of medical devices containing substances
    • Intrapreneurship and organisational skills
    • Analytical capacity
    • Excellent interpersonal skills
    • Good knowledge of English
    • Italian mother tongue or fluent
    • Knowledge of ISO 13485
    • Ability to write technical files of medical devices containing substances
    • Auditor course certificate (40 hours)


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