Job Description

As part of our continued growth, we are looking to recruit technical and experienced Medical Device Assessors/Lead Auditors. The successful candidates will be responsible for planning and conducting audits / assessments against the manufacturing of medical devices, in accordance with ISO 13485, IVDR 2017/745 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.
Scope

A Medical Device Auditor evaluates whether medical device companies comply with regulatory requirements and quality standards. 
Auditing Quality Management Systems (mainly ISO 13485).
Checking compliance with regulations (., EU MDR, FDA 21 CFR 820, MDSAP).
Assessing technical documentation, validation, and product safety evidence.
Reporting nonconformities, recommending corrective actions, and ensuring follow‑up.
Work collaboratively with cross‑function...
            

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