Med Device Auditor

Job Summary

We are seeking an experienced and detail-oriented Medical Device Auditor to evaluate and ensure compliance with medical device quality systems, regulatory requirements, and industry standards. The ideal candidate will conduct audits of manufacturing processes, quality management systems, supplier controls, and documentation practices to ensure compliance with FDA, ISO 13485, MDR, and other applicable regulations.

The candidate should possess strong analytical skills, deep understanding of quality assurance processes, and experience working within regulated medical device environments.

Key Responsibilities

• Conduct internal, supplier, and external audits for medical device manufacturing and quality systems.
• Evaluate compliance with:
  • ISO 13485
  • FDA 21 CFR Part 820
  • EU MDR / IVDR
  • GMP and GxP standards
• Review and assess:
  • CAPA processes
  • Risk management files
  • Design controls
  • Validation documentation
  • SOPs and quality records
• Identify non-conformances and compliance gaps.
• Prepare detailed audit reports and recommend corrective/preventive actions.
• Track audit findings through closure and verify effectiveness of remediation activities.
• Collaborate with Quality Assurance, Regulatory Affairs, Manufacturing, and Engineering teams.
• Support inspection readiness activities for FDA, notified bodies, and customer audits.
• Ensure documentation and records are maintained according to regulatory requirements.
• Provide guidance and training on compliance and quality standards.

Required Qualifications

• Bachelor’s degree in Biomedical Engineering, Life Sciences, Quality Management, Engineering, or related field.
• 5+ years of experience in medical device auditing, quality assurance, or regulatory compliance.
• Strong knowledge of:
  • ISO 13485
  • FDA Quality System Regulations (21 CFR Part 820)
  • Medical device manufacturing processes
  • CAPA and risk management
• Experience conducting supplier and internal audits.
• Excellent documentation, reporting, and communication skills.
• Ability to work independently and manage multiple audit activities.

Preferred Qualifications

• Certified ISO 13485 Lead Auditor.
• ASQ Certified Quality Auditor (CQA) or equivalent certification.
• Experience with EU MDR, IVDR, and global regulatory standards.
• Experience with software medical devices or SaMD compliance.
• Familiarity with validation protocols and quality engineering practices.

Technical Skills

• Quality Management Systems (QMS)
• CAPA Management
• Risk Management
• Audit Documentation
• Regulatory Compliance
• Root Cause Analysis
• Microsoft Office Suite
• Document Control Systems