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Apply online at https://www.etiometry.com/join-our-team/ or send resume to: Marcey Bowman, HR at mbowman@etiometry.com . Ref: 00077145. An EOE.
QA Validation Specialist
Location
United States
Posted
95 days ago
Salary
0
No structured requirement data.
Job Description
QA Validation Specialist
Etiometry Inc
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description 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. - 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 Qualifications - Bachelor’s degree in technical or clinical field - Minimum 5 years of 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 Benefits - Generous benefits package - Paid vacation and major holidays off - Flexible hours with work from home capabilities - Incentive Stock Options You might be a fit for Etiometry if - You are energetic and enjoy working in a fast-paced environment - You are confident and love sharing success with your team - You take ownership of your work and continuously strive for improvement Contact Us If you are interested in this opportunity, please email careers@etiometry.com with your resume.
Job Requirements
- Bachelor’s degree in technical or clinical field
- Minimum 5 years of 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
Benefits
- Generous benefits package
- Paid vacation and major holidays off
- Flexible hours with work from home capabilities
- Incentive Stock Options
- You might be a fit for Etiometry if
- You are energetic and enjoy working in a fast-paced environment
- You are confident and love sharing success with your team
- You take ownership of your work and continuously strive for improvement
- Contact Us
- If you are interested in this opportunity, please email careers@etiometry.com with your resume.
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