Software Quality Engineer (IVD)

Location: Fully remote; standard working hours are Monday through Friday, 9 AM to 5 PM EST

Salary: $111,249–$122,620 USD annually

Company

hirify.global develops genomics and diagnostic products focused on helping patients receive diagnoses earlier.

What you will do

• Execute software quality activities and support the development of SDLC quality-management-system processes.
• Review software design-control documentation, including requirements, architecture, code-review records, and verification and validation evidence.
• Support Design and Development File documentation throughout the product lifecycle.
• Provide quality guidance for software risk management, cybersecurity design controls, vulnerability management, and post-market activities.
• Support validation of operational and product-testing software tools and investigate software nonconformances, deviations, and CAPAs.
• Prepare software-related evidence for internal and external audits and contribute to regulatory and continuous-improvement activities.

Requirements

• Bachelor’s or advanced degree in computer science, engineering, bioinformatics, or a related scientific or technical field.
• 6+ years of software QA experience, including 4+ years in medical-device or FDA-regulated software development.
• Practical experience with design controls, ISO 13485, ISO 14971, and IEC 62304.
• Experience with Software as a Medical Device or medical devices containing software.
• Strong understanding of design-control procedures and software development lifecycles in regulated environments.
• Experience supporting regulatory submissions and audits, with the ability to manage multiple priorities in a fast-paced environment.

Nice to have

• Certified Software Quality Engineer (CSQE) certification.

Culture & Benefits

• Fully remote work from a home office or another suitable remote location.
• Work with genomics products intended to improve patient diagnosis.
• Culture emphasizing ownership, collaboration, high standards, continuous learning, and continuous improvement.
• Compensation and benefits reflect local market practices and legal requirements in each country where hirify.global operates.