Medical Device Auditor
5 giorni fa
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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