Document Control Analyst - eQMS & Compliance

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

Benefits offered by this job

Discretionary bonus

Medical, Vision & Dental coverage

401k

Paid vacation, holidays, and sick time

Job summary

Analog Devices, Inc. in Wilmington, MA is seeking an Analyst, Document Control to perform professional-level document control and training coordination within a regulated medical device manufacturing environment.

You will manage the document lifecycle in the eQMS, support quality system compliance with ISO 9001, IATF, FDA QMSR, and ISO 13485, and collaborate with Quality, Manufacturing, and Engineering to ensure audit readiness.

Qualifications

• 1–4 years of document control or regulated documentation in a medical device environment.
• Working knowledge of ISO 9001, IATF, FDA QMSR (21 CFR Part 820) and ISO 13485.
• 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.
• Identify discrepancies or compliance risks and recommend corrective actions.
• Administer eQMS user accounts, roles, permissions, and access; provide training and advanced support.

Skills

Analytical skills

Attention to detail

Professional communication

Education

Bachelor’s degree or equivalent professional experience

Job description

Analog Devices, Inc. in Wilmington, MA is seeking an Analyst, Document Control to perform professional-level document control and training coordination within a regulated medical device manufacturing environment.

You will manage the document lifecycle in the eQMS, support quality system compliance with ISO 9001, IATF, FDA QMSR, and ISO 13485, and collaborate with Quality, Manufacturing, and Engineering to ensure audit readiness.