medical device

Role & responsibilities

• Conduct audits of Medical Device QMS, primarily ISO 13485.
• Assess compliance with EU MDR, FDA 21 CFR 820 and MDSAP requirements.
• Review technical documentation, validation and product safety evidence.
• Identify and report non-conformities and ensure effective follow-up.
• Prepare accurate, error-free audit reports and coordinate with internal teams.
• Provide technical inputs to Sales and support customer engagements.
• Maintain auditor credentials and pursue relevant professional certifications.

Key Requirement:

• Experience in Sterilization of medical devices/products is mandatory.
• Strong knowledge of Medical Device Quality & Regulatory requirements.
• IRCA-approved ISO 13485 & MDR Assessor certifications preferred/required as applicable.
• Experience as a Lead Auditor in ISO 13485.