Senior Software Validation with Medical Device and IEC and ISO Exp

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.