Software Quality Engineer (Healthcare / GxP)

Software Quality Engineer (Healthcare / GxP) Lake Forest, IL 60045 $35

• $40 an hour
• Contract $35
• $40 an hour
• Contract About the Role We are seeking a Software Quality Engineer with experience in regulated healthcare, medical device, or GxP environments to support software quality and SDLC activities for healthcare-related applications and systems.

This role is ideal for candidates with experience in: software validation regulated SDLC defect lifecycle management compliance documentation end-to-end testing activities Key Responsibilities Execute and support Software Development Lifecycle (SDLC) activities in a regulated environment Perform manual and automated testing including: functional testing regression testing UAT testing validation testing Create, review, and approve: test protocols validation documents traceability documentation defect reports Manage and track software defects through the full lifecycle Collaborate with cross-functional teams including Quality, Engineering, and Compliance Ensure compliance with: GxP FDA internal quality systems Support risk management and software quality initiatives Utilize ALM/JIRA or similar tools for testing and defect management Required Qualifications 5+ years of Software Quality / SQA experience Experience in: medical device healthcare pharma FDA-regulated environments Strong understanding of: SDLC software validation defect lifecycle management Experience with: manual testing regression testing UAT validation protocols Familiarity with: GxP FDA regulations compliance documentation Preferred Qualifications Experience with:

IEC 62304 ISO 13485 21 CFR

Part 11 ALM / HP ALM experience Agile / Scrum environment exposure Cloud-based application testing Cybersecurity or validation experience Not a

Fit If You Only Have:

generic web QA banking QA e-commerce testing non-regulated software testing Healthcare / regulated industry experience is strongly preferred.

Ideal Backgrounds Candidates from:

Medical Device Diagnostics Healthcare Software FDA-Regulated Environments Examples:

Abbott Medtronic Baxter Stryker GE Healthcare Siemens Healthineers Roche Philips Healthcare Apply Now If you have experience in regulated software quality, validation, or healthcare SDLC environments , we'd love to connect with you.

Pay:

$35.00

• $40.

00 per hour

Benefits:

Employee assistance program Tuition reimbursement

Experience:

Medical Devices:

1 year (Required)

Work Location:

In person