CINCO Engineering

Quality Compliance Auditor

CINCO Engineering

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Job Level

Mid-LevelSenior

About the role

  • Serve operations in the regulated industry as a Quality Compliance Auditor
  • Ensure all services provided under the contract align with applicable regulatory requirements, client policies, and industry best practices
  • Conduct audits and assessments related to ISO, supplier quality, CAPA, investigations, management review, complaints, risk management, and validation
  • Support compliance activities including investigations, CAPA oversight, and supplier quality management
  • Report findings and recommend corrective/preventive actions to maintain regulatory compliance

Requirements

  • ISO Lead Auditor 9001 or 13485
  • Internal Auditor experience
  • Strong Background in Quality and Compliance (ISO related)
  • Regulated Environment Experience
  • Knowledge in: Supplier Quality management, CAPA, Investigations, Management Review, Complaints, Risk Management, Validation/CS
  • Bachelor’s degree in Life Sciences, Engineering, or related field
  • Minimum 5 years of compliance experience in a regulated environment (GxP, FDA, ISO)
  • Strong analytical, organizational, and communication skills
  • Bilingual (English/Spanish) preferred