Sr Quality Software Engineer (Remote)

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

1 Year Contract with Extension possibility

REMOTE - Ability to travel to Austin, TX

What You Can Expect

Seeking a detail-oriented Software Validation and Quality Sr Engineer (REMOTE) experienced in regulated environments, specializing in software quality review, compliance, and audit readiness, with hands‑on capability in validation and testing activities supporting FDA, IEC and ISO standards.

How You'll Create Impact

• Perform software quality review of requirements, design, and deliverables to ensure compliance with FDA, ISO and IEC 62304 standards.
• Ensure adherence to quality system processes and design control requirements across the software development lifecycle.
• Review and approve requirement specifications, test plans, validation protocols, traceability matrices (RTM), and validation reports.
• Support requirements activities by ensuring clarity, completeness, and testability of software requirements.
• Ensure end‑to‑end traceability between requirements, risk controls, and verification evidence.
• Participate in risk assessments and ensure proper implementation and verification of risk control measures.
• Participate in design reviews, code reviews, and quality reviews of software deliverables.
• Support change management activities, including impact assessment and documentation of software changes.
• Support validation and verification (V&V) activities by developing and executing test plans, test cases, and validation protocols as needed.
• Perform functional, integration, and system‑level testing for embedded software and cloud‑based systems to support product quality.
• Prepare and review validation documentation including test plans, protocols, reports, and compliance records.
• Support defect investigations to ensure proper root cause analysis and closure.
• Support audit readiness activities and regulatory inspections (FDA, ISO).
• This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

Skills

What Makes You Stand Out

• Strong understanding of software verification and validation (V&V) principles, including test coverage and objective evidence.
• Experience with validation deliverables including test plans, validation protocols, execution reports, and RTM.
• Familiarity with risk management processes and participation in risk assessments (ISO 14971).
• Experience with change management processes and impact assessment.
• Familiarity with configuration management practices, including version control and release traceability.
• Experience in design reviews, code reviews, and quality reviews of software systems.
• Knowledge of regulatory standards including FDA regulations, IEC 62304, GAMP 5, and 21 CFR Part 11.
• Prior experience working with cross‑functional teams including R&D, QA, and Regulatory.

Education

Your Background

• Minimum Requirements: Bachelor's Degree and 4 years of relevant experience or equivalent experience.
• Bachelor’s degree in computer science, computer engineering, or a related field is preferred.
• 4+ years of software validation and quality experience in a regulated environment (medical device preferred).