Document Control & Quality Systems Administrator

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.  

The Document Control & Quality Systems Administrator will work cross-functionally with Quality, Regulatory Affairs, Clinical Affairs, Engineering, Operations, and Manufacturing to support the effective operation of the QMS. This role will manage document lifecycle activities, training administration, calibration records, supplier documentation, record retention, finished goods documentation, and other critical quality system activities while identifying opportunities to improve efficiency and compliance.  

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, training management, and record retention requirements  

Experience supporting Quality System processes such as change control, CAPA, nonconformances, supplier management, audits, inspections, or calibration programs  

Experience maintaining accurate, traceable, and inspection-ready Quality System documentation  

Proficiency with Microsoft Office applications and electronic Quality Management Systems  

Strong organizational and time-management skills with the ability to independently manage multiple priorities and deadlines  

Exceptional attention to detail with a strong commitment to documentation accuracy and data integrity  

Strong written and verbal communication skills  

Ability to work independently while collaborating effectively across multiple functions  

Preferred Qualifications:  

Experience within an FDA-regulated medical device organization  

Experience with Arena or a comparable electronic Quality Management System  

Experience serving as an eQMS administrator, system owner, or power user  

Experience with eQMS validation, system configuration, workflow changes, or system enhancements  

Familiarity with FDA 21 CFR Part 820, 21 CFR Part 11, ISO 13485, and Good Documentation Practices  

Experience supporting FDA inspections, ISO certification audits, or other regulatory audits  

Experience with supplier administration, calibration programs, and manufacturing quality records  

Experience reviewing Lot History Records and supporting finished goods release  

Compensation:  

Base Pay: $120,000–$140,000 per year  

Annual Bonus Eligibility