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Compliance Auditor III

ATR International
Temecula, California, US
Full-time

Job Description :

We are seeking a Compliance Auditor III for a very important client Main Responsibility

  • Perform quality system and manufacturing process audits
  • Prepare audit report that establishes the outcome of the audit and the detail of non-conformances identified during the audits
  • Track audit results including corrective actions, and follow up to these actions as required
  • Support Client Third party and regulatory agency inspection as required
  • Provide support to SQA team as needed

Requirement :

The ideal candidate will possess the following qualifications : Experience / Background :

  • Related work experience with a strong understanding of audit process per ISO 13485 and FDA regulations for Medical Device
  • A minimum of 6 years working in Medical Device Industry
  • Good problem-solving skills and critical thinking
  • Demonstrate excellent interpersonal skills when dealing with internal and external customers
  • Demonstrate fact-based decision-making skill.
  • Communicate effectively both written and oral modes
  • Ability to work independently and effectively with other team members Education / Certification :
  • Bachelor Degree prefer in Science or Engineering
  • CQA (preferred)
  • 6 days ago
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