Senior Medical Device Auditor

3 weeks ago


South San Francisco, California, United States Experis Full time

Experis is seeking a highly skilled Certified ISO 13485 Auditor to lead their auditing activities in the pharmaceutical industry. The ideal candidate will have a strong background in medical device regulations and quality assurance.

Key Responsibilities:
  • Plan, lead, and conduct internal audits to ensure compliance with regulatory requirements.
  • Support the execution of audit strategies and lead process audits.
  • Document audit plans and reports.
  • Actively support regulatory inspections and prepare for FDA audits.
  • Identify and drive process improvements.
  • Assess operations for adherence to regulatory requirements and quality agreements.
  • Communicate with internal and external customers to ensure compliant resolution of project-related issues.
Requirements:
  • Associate's degree and at least 6 years of experience in medical device manufacturing or quality assurance.
  • Demonstrated knowledge of medical device regulations (FDA, ISO, MDSAP, IVDR).
  • Advanced computer skills in MS Office applications and knowledge of enterprise systems.
  • Certified ISO 13485:2015 Lead Auditor with auditing experience.
  • MDSAP auditor training with preferred experience obtaining/maintaining MDSAP Certificate.

As a leading global workforce solutions company, Experis helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills.



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