QA Validation Specialist

Etiometry Inc

1d•Remote

About The Position

We are seeking a meticulous QA Validation Specialist to ensure the integrity and performance of our ICU software solutions across our customer base. In this role, you will be responsible for validating software configurations, maintaining compliance with regulatory standards, and serving as a technical resource throughout the customer lifecycle. You'll work at the intersection of quality assurance, customer implementation, and clinical operations—ensuring our software performs flawlessly in real-world ICU environments.

Requirements

Bachelor’s degree in technical or clinical field
Minimum 5 years pf experience in healthcare IT or medical device industry
Minimum 3 years in a software testing, quality assurance or requirements validation role
Minimum 3 years interfacing with clinical and technical resources
Familiar with clinical workflows and associated datatypes, preferably in critical care areas like ICU, ED and OR
Ability to identify clinically implausible scenarios by reviewing data
Demonstrated understanding of medical device regulations and quality systems (FDA, ISO standards) in prior roles
Strong attention to detail and documentation skills
Excellent communication skills for customer-facing interactions
Ability to learn technical software systems quickly
Problem-solving mindset with technical troubleshooting abilities
Experience with regulatory compliance documentation
Self-starter with ability to self-manage and prioritize daily work

Responsibilities

Participate in customer-facing implementation meetings to gather configuration requirements and align expectations across all customer stakeholders
Create and maintain Clinical Requirements Documents for each ICU customer throughout their entire lifecycle
Update Clinical Requirements Documentation with new functionality configuration options accompanying each software release
Conduct comprehensive site checks following each software update, prior to team site visits, and on a periodic basis to verify proper software functionality
Develop and maintain validation protocols to be executed during site checks
Ensure all activities comply with regulatory requirements and the company's quality management system
Serve as the remote technical liaison for Etiometry staff during on-site visits, providing real-time troubleshooting support
Collect and document metrics and anecdotal findings through site checks for internal reporting and performance evaluation
Maintain accurate records of all validation activities and customer configurations