Senior Quality Engineer (Medical Devices)

Location: Hybrid role requiring three days per week in the office, based in Chicago or Aliso Viejo, California.

Salary: $90,000–$130,000 per year for the Chicago range; $100,000–$150,000 per year for the NYC/SF range.

Company

hirify.global develops a precision medicine platform that connects real-world evidence with clinical insights to support treatment decisions.

What you will do

• Lead verification, validation, and maintenance of host systems supporting medical devices.
• Define risk-based strategies for host and computer system validation, software development lifecycle activities, and design controls.
• Perform validation, re-validation, and change controls for AI, SaaS, and internally developed software.
• Author and review risk assessments, validation plans, user requirements, protocols, user acceptance tests, and validation reports.
• Collaborate with quality, IT, test engineering, and cross-functional teams on requirements, testing strategies, and test execution.
• Support change management, major incident processes, audits, inspections, compliance activities, and team training.

Requirements

• Bachelor’s degree or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical Engineering, or a related discipline.
• At least five years of experience in an FDA-regulated domain such as medical devices, pharmaceuticals, or biotechnology.
• At least three years of experience in Computer System Validation.
• Experience with medical device software standards and practices, including Design Controls, GAMP 5, FDA 21 CFR Part 11, FDA 21 CFR 820.30, ISO 13485:2016, FDA Quality System Regulation, and IEC 62304:2006.
• Knowledge of quality system principles, practices, and standards for the life sciences industry.
• Ability to deliver high-quality work independently or with minimal supervision.

Culture & Benefits

• Work in a precision medicine and healthcare technology environment.
• Benefits may include incentive compensation, restricted stock units, medical benefits, and other company benefits depending on the position.
• Equal opportunity employment with consideration for qualified applicants in accordance with applicable law.