Analyst, Document Control

Analog Devices•Wilmington, MA

1d•Onsite

About The Position

Performs professional-level document control and training coordination within a regulated medical device manufacturing environment. Applies working knowledge of quality management systems (QMS) and electronic quality management systems (eQMS) to manage the document lifecycle, support the organization’s training program, maintain system integrity, and sustain audit readiness. Operates with increasing autonomy within established policies and procedures, applying sound judgment to deliver accurate, timely, and compliant results.

Requirements

1–4 years of experience in Document Control, Quality Systems, or regulated documentation within a medical device environment.
Working knowledge of applicable ISO 9001, IATF, FDA Quality Management System Regulation (QMSR), and ISO 13485 requirements and document control principles.
Strong analytical skills, attention to detail, and professional communication capability.
Bachelor’s degree or equivalent professional experience.

Responsibilities

Execute document creation, revision, routing, approval, publishing, and archival activities in the eQMS in compliance with QMS requirements.
Review documentation for completeness, format adherence, and procedural compliance prior to system release.
Apply professional judgment to identify document discrepancies, inconsistencies, or compliance risks and recommend corrective actions.
Administer eQMS user accounts, roles, permissions, and access.
Provide eQMS user training and advanced support, troubleshoot system issues, and perform approved system configuration activities.
Configure and maintain training assignments, courses, and roles within the eQMS.
Manage the periodic review process and ensure reviews are completed in accordance with established requirements.
Monitor, and report key performance indicators (KPIs) that measure the effectiveness, compliance, and performance of Document Control processes.
Support audits and inspections conducted against applicable ISO, IATF, and FDA requirements, including the FDA Quality Management System Regulation (QMSR) under 21 CFR Part 820, by preparing documentation packages, retrieving records, and responding to auditor inquiries under guidance.
Ensure document linkages, including training assignments, records, and obsolete-document controls, are accurately maintained within the eQMS.
Partner professionally with authors, reviewers, and approvers across Quality, Manufacturing, and Engineering.
Communicate document status, issues, and required actions clearly to stakeholders.
Maintain high standards of system accuracy, data integrity, and compliance.
Escalate systemic or policy‑related issues through appropriate professional channels.