Rakuten Medical

Rakuten Medical, Inc. is a global biotechnology company in pursuit of conquering cancer.

Quality Systems Engineering Manager

Systems EngineerSystems EngineerFull TimeRemoteTeam 201-500Since 2010H1B No SponsorCompany SiteLinkedIn

Location

California

Posted

16 days ago

Salary

$140K - $160K / year

Bachelor Degree8 yrs expEnglish

Job Description

• Oversee the implementation, maintenance, and improvement of the QMS • Lead Management Reviews and ensure top-level quality engagement • Conduct internal audits and prepare for external inspections • Manage document control processes utilizing Arena for product lifecycle management • Oversee supplier qualification and auditing processes • Own and manage the CAPA and non-conformance systems

Job Requirements

  • Bachelor’s degree in Engineering, Life Sciences, or related field
  • ISO 13485:2016 Lead Auditor Certification (required)
  • Minimum 8-10 years of experience managing quality systems in regulated industries
  • Strong working knowledge of ISO standards and FDA regulations
  • Proficiency in QMS software (e.g., Arena, MasterControl)

Benefits

  • Flexible time off
  • Stock options
  • 401k
  • Medical plans
  • Dental plans
  • Vision plans

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