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Job Title: Software Quality Engineer (Validation & Quality)
Location: Remote – United States
Employment Type: Contract
Work Authorization: USC Only
Job Summary
We are seeking an experienced Software Quality Engineer (Validation & Quality) to support software quality assurance, validation, and compliance activities within a regulated medical device environment.
The ideal candidate will have strong experience in software validation, quality systems, design controls, and regulatory compliance while supporting software lifecycle and remediation activities for medical device products.
Key Responsibilities
- Support software quality assurance and validation activities for medical device software systems
- Develop, review, and execute validation documentation including:
- IQ/OQ/PQ Protocols
- Test Plans
- Validation Reports
- Traceability Matrices
- Support software design controls and remediation activities
- Collaborate with Software Engineering, Quality, Regulatory, and Validation teams
- Ensure compliance with FDA regulations, IEC 62304, ISO 13485, and company quality standards
- Support risk management, CAPA, deviation, and change control activities
- Participate in software verification and validation (V&V) testing
- Maintain audit-ready documentation and quality records
Required Qualifications
- Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, or related field
- Strong experience in software quality engineering and validation within the medical device industry
- Hands-on experience with:
- Software Validation
- Design Controls
- SDLC Documentation
- Verification & Validation (V&V)
- Risk Management
- Strong understanding of:
- FDA regulations
- IEC 62304
- ISO 13485
- 21 CFR Part 11
- Excellent technical writing, analytical, and communication skills
- Ability to work independently in a remote environment
Preferred Skills
- Experience supporting remediation or compliance-driven projects
- Familiarity with CAPA, change control, and DHF documentation
- Experience with Agile or regulated software development environments
- Knowledge of cybersecurity or SaMD (Software as a Medical Device) is a plus
