Document Control & Quality Systems Administrator

noctrixhealth; United States; Hybrid; USD 85,000 - 110,000; Full time

Job summary

Noctrix Health seeks a seasoned Document Control & Quality Systems Administrator to oversee the day-to-day administration of our QMS and eQMS, ensuring documents, training records, and quality records are accurate and inspection-ready, while supporting cross-functional teams.

Reporting to the Director of Quality, this full-time role can be remote or hybrid from Pleasanton, and will coordinate with Regulatory, Engineering, and Operations to sustain compliant processes and improve efficiency.

Qualifications

• Associate's or Bachelor's degree in scientific/technical/quality field.
• Minimum 3 years in document control or Quality Systems within regulated industry.
• Experience administering document control systems and eQMS platforms.
• Working knowledge of FDA Quality System requirements and ISO 13485.

Responsibilities

• Administer the eQMS and document control templates, workflows, and approvals.
• Manage lifecycle of controlled documents including formatting, routing, review, issuance and archival.
• Coordinate training programs, and maintain electronic training records and training matrices.
• Monitor compliance and support internal and supplier audits, CAPA and change control activities.
• Support calibration records management and supplier quality documentation.

Skills

Document control

Quality Systems administration

Training administration

Quality Assurance

Education

Associate's or Bachelor's degree in a scientific, technical, quality, or related discipline

Tools

eQMS platforms

Document control software

Job description

Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering prescription-grade therapy with an outstanding user experience. We have pioneered the world's first drug-free wearable therapy, clinically proven to alleviate symptoms in adults with drug-resistant Restless Legs Syndrome (RLS). Join us in transforming healthcare, improving lives, and driving meaningful change through innovative medical technology.

We are seeking an experienced and highly organized Document Control & Quality Systems Administrator to manage the day-to-day administration of document control and key Quality Management System (QMS) processes at Noctrix Health. This individual will serve as the primary administrator for controlled documents, employee training records, quality records, and the electronic Quality Management System (eQMS), ensuring information remains accurate, current, traceable, compliant, and inspection-ready.

This position reports to the Director, Quality . This is a full-time position that may be performed remotely or in a hybrid capacity at our Pleasanton headquarters.

Responsibilities:

• Serve as the primary administrator for Noctrix Health's document control and electronic Quality Management System (eQMS), ensuring compliance with internal procedures and applicable regulatory requirements
• Manage the complete lifecycle of controlled documents, including formatting, routing, review, approval, issuance, revision, obsolescence, archival, and retention
• Administer eQMS workflows, user access, system data integrity, and routine system maintenance
• Perform and document eQMS validation activities associated with changes to document control templates, workflows, and applicable system functionality
• Develop, maintain, and continuously improve document control procedures, templates, workflows, and related Quality System documentation
• Administer the company's quality training program, including training assignments, completion tracking, training matrices, and electronic training records
• Monitor training compliance and partner with department leaders to ensure required training is completed accurately and within established timelines
• Provide training and ongoing user support for document control, training, and eQMS processes
• Maintain calibration records and coordinate calibration activities with approved service providers to ensure equipment remains compliant with applicable requirements
• Administer the Approved Supplier List and support the Supplier Management Program, including supplier records, qualification status, reassessments, audit schedules, and quality agreements
• Manage Quality System records and archives in accordance with company procedures and applicable record retention requirements
• Review Lot History Records (LHRs) for completeness and compliance with Good Documentation Practices (GDP), resolve identified documentation issues, and support finished goods release to inventory
• Support Quality System processes including change control, Management Review, Design Reviews, CAPA, nonconformances, complaints, supplier management, audits, inspections, and validation activities
• Prepare, organize, and maintain inspection-ready records for internal audits, supplier audits, regulatory inspections, and certification audits
• Partner cross-functionally with Quality, Regulatory Affairs, Clinical Affairs, Engineering, Operations, and Manufacturing to ensure timely execution of Quality System activities
• Identify and implement opportunities to improve document control and Quality System administration for greater efficiency, consistency, data integrity, and compliance
• Provide additional Quality Systems and operational support as organizational needs evolve

Requirements:

• 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 the medical device, biotechnology, pharmaceutical, or other regulated industry
• Demonstrated experience administering document control systems, training systems, eQMS platforms, and Quality System records
• Working knowledge of FDA Quality System requirements, ISO 13485, document control principles, electronic records,