Lead Auditor Specialist for In-Vitro Diagnostic Medical Devices
1 dia atrás
We are a leading testing, inspection, and certification company with a global presence.
Job SummaryWe seek an experienced lead auditor to join our team in the field of in-vitro diagnostic medical devices. The successful candidate will be responsible for conducting audits, mentoring junior colleagues, and contributing to the development of our IVDR certification service.
Key Responsibilities:- Support the qualification of new auditors by witnessing their qualification audits and providing feedback.
- Mentor junior colleagues and help coordinate the expansion of our IVDR auditor network.
- Contribute to the continuous improvement of our processes and tools used in conducting IVDR conformity assessments.
- Conduct on-site and remote audits, maintaining high standards of service delivery and ensuring compliance with regulatory requirements.
To be successful in this role, you will need:
- A minimum of 4 years' experience in designing, manufacturing, or testing IVDs.
- At least 2 years of quality assurance/quality management experience under a structured quality management system.
- A university degree in a relevant science or engineering field.
- Knowledge of EU IVDR 2017/746 and other relevant regulations.
- Strong English written and verbal skills.
We offer a competitive salary range of $80,000 - $120,000 per year, depending on experience. Other benefits include opportunities for professional growth and development, a dynamic work environment, and a comprehensive compensation package.
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