Software Quality Engineer (Healthcare / GxP)

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, * 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

Do you have experience in User acceptance testing?, * 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.

$35 - $40 an hour - Contract, Pulled from the full job description

• Tuition reimbursement
• Employee assistance program, * Medical Device
• Diagnostics
• Healthcare Software
• FDA-Regulated Environments

Examples:

• Abbott
• Medtronic
• Baxter
• Stryker
• GE Healthcare
• Siemens Healthineers
• Roche
• Philips Healthcare