Document Control & Quality Systems Specialist

Noctrix Health; Pleasanton (CA); Hybrid; USD 120,000 - 140,000; Full time

Job summary

Noctrix Health in Pleasanton, CA seeks a seasoned Document Control & Quality Systems Administrator to manage the eQMS, training records, and controlled documents, ensuring compliance and inspection readiness.

You will collaborate with Quality, Regulatory, Clinical, Engineering, and Manufacturing to maintain document lifecycles, calibration records, supplier docs, and archival processes, while driving efficiency.

Qualifications

• Associate’s or Bachelor’s degree in a scientific, technical, quality, business administration, or related discipline
• Minimum of 3 years of experience in document control, Quality Systems administration, training administration, or Quality Assurance within regulated industries
• Experience administering document control systems, training systems, eQMS platforms, and Quality System records
• Knowledge of FDA Quality System requirements, ISO 13485, document control principles, electronic records, training management, and record retention
• Experience supporting Change Control, CAPA, nonconformances, supplier management, audits, inspections, or calibration programs
• Experience maintaining accurate, traceable Quality System documentation
• Proficiency with Microsoft Office and eQMS tools
• Strong organizational and time-management skills with attention to data integrity
• Excellent written and verbal communication skills
• Ability to work independently across multiple functions

Responsibilities

• Serve as the primary administrator for Noctrix Health’s document control and eQMS
• Manage lifecycle of controlled documents including formatting routing review and retention
• Administer eQMS workflows user access and data integrity
• Conduct eQMS validation activities for template/workflow changes
• Develop and improve document control procedures templates and workflows
• Administer the company’s quality training program and tracking systems
• Monitor training compliance and coordinate with department leaders
• Provide training and ongoing user support for document control and eQMS
• Maintain calibration records and coordinate calibration activities
• Manage Approved Supplier List and supplier quality documentation
• Maintain Quality System records and archives
• Review Lot History Records for GDP compliance and support finished goods release
• Support Quality System processes: change control CAPA nonconformances audits inspections validation
• Prepare inspection-ready records for internal and regulatory audits
• Collaborate cross-functionally to ensure timely QMS activities
• Identify opportunities to improve document control and Quality System administration
• Provide additional Quality Systems support as needed

Skills

Document control

Quality Systems

Training administration

Regulatory awareness

Attention to detail

Communication

Independent work

Education

Associate’s or Bachelor’s degree in a scientific/technical/quality field

Tools

Arena eQMS

Microsoft Office

Job description

Noctrix Health in Pleasanton, CA seeks a seasoned Document Control & Quality Systems Administrator to manage the eQMS, training records, and controlled documents, ensuring compliance and inspection readiness.

You will collaborate with Quality, Regulatory, Clinical, Engineering, and Manufacturing to maintain document lifecycles, calibration records, supplier docs, and archival processes, while driving efficiency.