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
