Rakuten Medical
via Remote Rocketship
Quality Systems Engineering Manager
Compensation
$140000K-160000K a year
Responsibilities
Lead and manage quality management systems, audits, and compliance in regulated industries.
Requirements
Requires 8-10 years managing quality systems, ISO Lead Auditor certification, and proficiency with QMS software.
Full Description
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 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
This job posting was last updated on 2/24/2026
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