Remote Quality Systems & Document Control Lead

Noctrix Health, Inc.; United States; Hybrid; USD 120,000 - 140,000; Full time

Job summary

Noctrix Health, Inc. is seeking a highly organized Document Control & Quality Systems Administrator to manage the day-to-day administration of document control and QMS processes.

This role ensures controlled documents, training records, quality records, and the eQMS are accurate, current, traceable, compliant, and inspection-ready. The position collaborates with Quality, Regulatory Affairs, Clinical Affairs, Engineering, Operations, and Manufacturing to support QMS activities, training,

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.
• 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).
• 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

Organizational skills

Time-management

Attention to detail

Communication skills

Problem-solving

Independent worker

Education

Associate's or Bachelor's degree in scientific/technical/quality/business administration

Tools

Arena eQMS

eQMS platforms

Microsoft Office

Job description

Noctrix Health, Inc. is seeking a highly organized Document Control & Quality Systems Administrator to manage the day-to-day administration of document control and QMS processes.

This role ensures controlled documents, training records, quality records, and the eQMS are accurate, current, traceable, compliant, and inspection-ready. The position collaborates with Quality, Regulatory Affairs, Clinical Affairs, Engineering, Operations, and Manufacturing to support QMS activities, training,