Remote Quality Systems & Documentation Administrator

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

Job summary

Noctrix Health, Inc. is seeking a skilled 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 role will serve as the primary administrator for controlled documents, training records, quality records, and the eQMS, ensuring information remains accurate, current, traceable, compliant, and inspection-ready.

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 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.

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

Skills

Document control

Quality Systems

Training administration

eQMS

Regulatory knowledge

Attention to detail

Communication skills

Organization

Education

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

Tools

Arena

eQMS platforms

Job description

Noctrix Health, Inc. is seeking a skilled 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 role will serve as the primary administrator for controlled documents, training records, quality records, and the eQMS, ensuring information remains accurate, current, traceable, compliant, and inspection-ready.