Medical Device D

3 weeks ago

Ontario, Canada Accuro Full time

Title: Medical Device Auditor must be ISO 13485 Certified Lead Auditor. Job Type: Contract
Location: Canada (Remote)
Qualifications:
Bachelor’s degree in Life Sciences, IT, Engineering, or related field.
Proven experience auditing medical devices and/or IT systems, preferably in a healthcare or medical manufacturing environment.
Strong knowledge of medical device regulations (FDA 21 CFR Part 820, ISO 13485, IEC 62304) and IT security standards.
Familiarity with risk management frameworks and software validation processes.
Certifications like CISA, ISO Lead Auditor, or equivalent are a plus.

Key Responsibilities:
Conduct thorough audits of medical devices and IT infrastructure to verify compliance with industry regulations (FDA, ISO, HIPAA, etc.) and company standards.
Assess risk management processes related to medical device use and data security.
Generate clear, concise audit reports highlighting findings, risks, and suggested improvements.

Regards
Anurag Kumar | Sr. Account Manager
Direct:: 919-626-9658| EMAIL anurag.ks@accurogroup.com

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