Position Summary

The Quality Systems Manager is responsible for managing the integrity, accuracy, and compliance of controlled documents within the organization’s electronic Quality Management System (eQMS). This role supports the operational administration of key QMS processes, including document control, training program coordination, audit documentation workflows, and monitoring of regulatory standards updates.  Reporting to the Director of Quality Systems, this position ensures controlled documentation and training records are maintained in compliance with FDA 21 CFR Part 11, ISO 13485, and applicable GxP requirements in a regulated environment.

 

Job Requirements

  • Administer document control and training workflows within the eQMS.
  • Manage the lifecycle of controlled documents, including creation, revision, approval, distribution, and archival, in accordance with company procedures and regulatory requirements.
  • Ensure all controlled documents (SOPs, work instructions, forms, specifications, policies) are accurate, current, and accessible to authorized personnel.
  • Maintain compliance with FDA 21 CFR Part 11, ISO 13485, and applicable GxP standards across all document control activities.
  • Provide administrative support for internal and external audits by organizing documentation, maintaining audit records in the eQMS, and tracking audit responses and related actions.
  • Support FDA inspections, Notified Body audits, and internal quality audits by retrieving and organizing controlled records.
  • Maintain the training curricula matrix within the eQMS based on requirements defined by system owners an functional leaders.
  • Assign and track employee training within the eQMS in accordance with the approved training curricula matrix and generate training compliance reports.
  • Identify opportunities for continuous improvement within the document control and training processes.
  • Monitor regulatory databases and standards updates to ensure referenced regulations and standards remain current; escalate potential changes to appropriate functions for evaluation.  
  • Generate reports and metrics related to document control, training compliance, and audit tracking to support Quality Systems monitoring.
  • May perform work as a Quality System Owner.
  • Additional duties as assigned.

 

Qualifications

  • 3–5 years of document control or quality systems experience in a regulated medical device or life sciences environment.
  • Hands-on experience working within eQMS platforms.
  • Demonstrated working knowledge of FDA 21 CFR Part 11, ISO 13485, and GxP documentation and record management requirements.
  • Strong attention to detail with the ability to manage multiple concurrent tasks and deadlines.
  • Excellent written and verbal communication skills; ability to coordinate across departments.
  • Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
  • Ability to travel domestically and internationally, as required.