ISO 13485 Auditor

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  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
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ISO 13485 Auditor

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    ISO 13485 Auditor
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DAVIS Companies has partnered with a leader in Medical Device manufacturing to identify an ISO 13485 Auditor to join their team! 

Qualifications Of the ISO 13485 Auditor: 

  • 5+ years of practical Medical Device Quality Experience supporting all elements of Quality Management System development, maintenance and improvement front Room audit experience in FDA investigation or Notified Body Audits
  • CAPA / NCR: Risk Assessment, Root Cause Investigation, Action Planning, including Verifying effectiveness
  • Experience in auditing to medical device standards (ISO 13485) and regulations (FDA QSR) – Certified Lead Auditor

Preferred Qualifications of the ISO 13485 Auditor: 

  • Familiar with SmartSolve, Salesforce, Navision, Agile software
  • Experience in Complaint Handling, Medical Device Reporting and Post-Market Surveillance



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