Senior IT BA – Life Sciences Quality & eQMS

Dignifyd; Mundelein (IL); On-site; USD 110,000 - 160,000; Full time

Job summary

Dignifyd in Mundelein, IL is seeking a Business Analyst focused on Life Sciences and medical device quality regulations. You will apply GxP thinking, map processes, craft user stories and support regulatory programs across FDA/regulatory frameworks.

You bring 8+ years of BA experience in life sciences or quality/regulatory roles, strong knowledge of QMS and compliance, and familiarity with eQMS/LIMS/MES and validation approaches such as GAMP 5.

Qualifications

• 8+ years as a Business Analyst in Life Sciences or Medical Device/Quality/regulatory functions.
• Strong domain knowledge of quality management systems and regulations including FDA 21 CFR Part 820, ISO 13485, 21 CFR Parts 210 & 211, 21 CFR Part 11, and EU MDR with EUDAMED.
• Experience with eQMS, PLM design control, LIMS, MES, and electronic device history record platforms.
• Experience with requirements management, process mapping, and user story writing.
• Experience supporting validation under Computer Software Assurance or GAMP 5.
• FDA-related experience such as remediation of warning letters or consent decrees is preferred.
• Understanding of AI applications in quality and compliance is a significant advantage.

Skills

GxP knowledge

FDA regulations

QMS regulations

Requirements management

Process mapping

User story writing

Validation experience

AI in QA/compliance

Tools

TrackWise

ETQ

MasterControl

Veeva Vault Quality

PTC Windchill

STARLIMS

Rimsys

Jira

Azure DevOps

eQMS

Job description

Dignifyd in Mundelein, IL is seeking a Business Analyst focused on Life Sciences and medical device quality regulations. You will apply GxP thinking, map processes, craft user stories and support regulatory programs across FDA/regulatory frameworks.

You bring 8+ years of BA experience in life sciences or quality/regulatory roles, strong knowledge of QMS and compliance, and familiarity with eQMS/LIMS/MES and validation approaches such as GAMP 5.