JOB DESCRIPTION
We are seeking a Senior Software Validation & Quality Engineer with experience in regulated environments, preferably medical devices. The ideal candidate will support software quality, validation, testing, compliance, and audit readiness.
Key Responsibilities
- Review software requirements, design documents, test plans, validation protocols, and reports.
- Support software V&V, functional/integration/system testing, and validation activities.
- Maintain requirements traceability (RTM) and verification evidence.
- Support risk management, change control, configuration management, and defect investigations.
- Participate in design, code, and quality reviews.
- Support FDA/ISO audits and regulatory compliance activities.
Must-Have Skills
- 4+ years of Software Validation/Quality experience in a regulated environment.
- IEC 62304, ISO 14971, FDA regulations, 21 CFR Part 11, GAMP 5
- Software V&V, validation protocols, test plans/cases, RTM.
- Risk management, change management, and configuration/version control.
- Experience with embedded and/or cloud-based software testing.
- Strong documentation and cross-functional collaboration skills.
- Bachelor s degree or equivalent experience.
Rate:
Not specified
Location:
Remote
IR35 Status:
Outside
Remote Status:
Remote
Industry:
Engineering
Seniority Level:
Mid-Level