Document Control & Quality Systems Administrator
N
Noctrix HealthMedical Device
Pleasanton, CA (Hybrid) / RemoteFull-TimeMiddle
SalaryBase Pay: $120,000–$140,000 per year
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Job Details
- Experience
- 3 years
- Required Skills
- Microsoft OfficeQuality Assurance
Requirements
- Associate’s or Bachelor’s degree in a scientific, technical, quality, or business-related field.
- Minimum of 3 years of experience in document control, Quality Systems, or QA in regulated industries.
- Demonstrated experience administering document control systems and eQMS platforms.
- Working knowledge of FDA Quality System requirements and ISO 13485.
- Experience supporting processes such as change control, CAPA, nonconformances, and supplier management.
- Proven ability to maintain inspection-ready Quality System documentation.
- Proficiency with Microsoft Office applications.
- Strong organizational and time-management skills.
- Exceptional attention to detail and data integrity.
- Strong written and verbal communication skills.
Responsibilities
- Manage the lifecycle of controlled documents from creation through archival.
- Administer eQMS workflows, user access, and system data integrity.
- Perform eQMS validation activities for system changes and templates.
- Maintain the company quality training program and monitor compliance.
- Coordinate calibration activities and manage calibration records.
- Administer the Approved Supplier List and support supplier management programs.
- Review Lot History Records (LHRs) and support finished goods release.
- Support Quality System processes like change control, CAPA, and internal/external audits.
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