Remote Software Validation & Quality Engineer FDA/ISO Focus

Aequor; United States; Remote; USD 120,000 - 150,000; Full time

Job summary

Aequor is seeking a detail-oriented Software Validation and Quality Senior Engineer for a 1 year contract with extension potential. This REMOTE role requires experience in regulated environments, including FDA, IEC, and ISO standards.

Occasional travel to Austin, TX is expected to support on-site audits and integration efforts. You will design and execute validation activities, review requirements and risk controls, maintain traceability matrices, and ensure audit readiness across embedded and

Qualifications

• Bachelor's degree and 4+ years in software validation in regulated environments
• Experience with FDA/IEC/ISO standards and software validation lifecycle
• Ability to create and review validation documentation including test plans/reports
• Strong understanding of traceability, risk management and design controls

Responsibilities

• Perform software quality review to ensure compliance with FDA, ISO and IEC 62304 standards
• Develop and execute test plans, validation protocols, and RTMs
• Ensure end-to-end traceability between requirements and verification evidence
• Support audit readiness and regulatory inspections

Skills

V&V principles

Test plans

RTM

Risk assessment

Change management

Configuration management

Design reviews

Regulatory knowledge

Cross-functional teamwork

Education

Bachelor's degree in CS/CE

Job description

Aequor is seeking a detail-oriented Software Validation and Quality Senior Engineer for a 1 year contract with extension potential. This REMOTE role requires experience in regulated environments, including FDA, IEC, and ISO standards.

Occasional travel to Austin, TX is expected to support on-site audits and integration efforts. You will design and execute validation activities, review requirements and risk controls, maintain traceability matrices, and ensure audit readiness across embedded and