Document Control Specialist – eQMS & Process Improvement

Insight Global; Beverly (MA); On-site; USD 43,000 - 54,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) after 90 days

Paid sick leave and PTO

Job summary

Insight Global is seeking a Document Control Associate to support rebuilding its quality documentation processes. You will manage controlled documents, run change orders, and ensure SOPs and forms align with quality procedures.

You will also identify process improvements and own the lifecycle of documentation from creation to archiving. The ideal candidate has 2–4 years in document control within regulated manufacturing, with experience in eDMS/eQMS, ECOs, revisions, and approvals.

Qualifications

• 2–4 years document control experience in regulated manufacturing (medical device, biopharma, pharma).
• Experience with eDMS/eQMS and ECOs/change orders including revisions, approvals, releases, and lifecycle.
• Independent mindset to identify problems and improve documentation processes.
• ISO 13485 knowledge and CAPA/audit experience preferred.
• Technical writing experience.

Responsibilities

• Manage controlled documentation within a document management system; run change orders and ensure SOPs, work instructions, specs, forms, and product docs follow quality procedures.
• Evaluate current processes and own improvements to how documentation is created, reviewed, approved, revised, distributed, and archived.

Skills

Document control

eDMS/eQMS

ECOs/change orders

Lifecycle management

Process improvement

ISO 13485

CAPA/audit experience

Technical writing

Tools

eDMS/eQMS software

Job description

Insight Global is seeking a Document Control Associate to support rebuilding its quality documentation processes. You will manage controlled documents, run change orders, and ensure SOPs and forms align with quality procedures.

You will also identify process improvements and own the lifecycle of documentation from creation to archiving. The ideal candidate has 2–4 years in document control within regulated manufacturing, with experience in eDMS/eQMS, ECOs, revisions, and approvals.