Quality System Consultant Job at Lumicity, San Jose, CA

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  • Lumicity
  • San Jose, CA

Job Description

Role: QMS Consultant

Location: San Francisco Bay Area

Duration: 6 Months (likely extensions)

Hours: 10-15 hours a week (could easily ramp up to 20/30 hours)

Key Responsibilities:

  • Act as the Quality Management Representative, reporting on QMS performance and promoting regulatory awareness.
  • Ensure audit readiness and lead interactions with regulatory bodies.
  • Maintain and improve quality procedures and documentation.

Qualifications:

  • 10+ years of quality experience in medical devices.
  • Strong understanding of ISO 13485, 21 CFR Part 820, ISO 14971; MDSAP and MDR knowledge a plus.
  • Experienced in QMS tools and audit processes.
  • ISO 13485 Lead Auditor certification required; ASQ certifications preferred

If interested, please apply now by attaching your resume!

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