Medical Device Document Control Analyst

Analog Devices, Inc.; Wilmington (MA); On-site; USD 69,000 - 95,000; Full time

Benefits offered by this job

Medical coverage

Vision and dental coverage

401k

Paid vacation

Holidays

Sick time

Other benefits

Job summary

Analog Devices, Inc. in Wilmington, MA is seeking a Document Control professional to manage the document lifecycle within a regulated medical device environment.

You will ensure accuracy, compliance, and audit readiness by handling creation, revision, routing, and archiving in the eQMS. The role requires 1–4 years in document control or quality systems, familiar with ISO 9001, IATF, FDA QMSR, and ISO 13485.

Qualifications

• 1–4 years of experience in Document Control, Quality Systems, or regulated documentation within a medical device environment.
• Working knowledge of ISO 9001, IATF, FDA QMSR, and ISO 13485 requirements and document control principles.
• Strong analytical skills, attention to detail, and professional communication capability.

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 KPIs that measure the effectiveness, compliance, and performance of Document Control processes.

Skills

Document Control

Quality Systems

Regulated documentation

Analytical skills

Education

Bachelor’s degree or equivalent

Tools

eQMS

QMS

Job description

Analog Devices, Inc. in Wilmington, MA is seeking a Document Control professional to manage the document lifecycle within a regulated medical device environment.

You will ensure accuracy, compliance, and audit readiness by handling creation, revision, routing, and archiving in the eQMS. The role requires 1–4 years in document control or quality systems, familiar with ISO 9001, IATF, FDA QMSR, and ISO 13485.