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Rakuten Medical, Inc. is a global biotechnology company in pursuit of conquering cancer.
Quality Systems Engineering Manager
Location
California
Posted
111 days ago
Salary
$140K - $160K / year
Seniority
Lead
Job Description
Quality Systems Engineering Manager
Rakuten Medical
• 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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