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Analog Devices

Designs high-performance analog and DSP ICs

Analyst – Document Control

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeWilmington, MA, USAIn-person

About the Job

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), 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 electronic quality management system (eQMS) in compliance with quality management system (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 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.

About the Company

Analog Devices

Designs high-performance analog and DSP ICs

Analog Devices designs, manufactures, and markets high-performance analog, mixed-signal, and DSP integrated circuits used in many electronic devices. Its products include data converters, amplifiers, and power-management ICs that OEMs embed to sense, convert, and process signals, enabling reliable communication between the physical world and digital systems. ADI differentiates itself through a broad, specialized portfolio and close partnerships with OEMs across multiple industries—industrial, automotive, communications, and consumer—to solve complex engineering challenges. The company’s goal is to provide trusted signal-processing solutions that help customers design capable, reliable products by bridging the gap between the physical and digital domains.

Company size
10,001+
Company stage
IPO
Headquarters
Wilmington, MA
Founded
1965

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