Remote Software Quality Engineer – IVD/Medical Device

GeneDx; United States; On-site; USD 111,000 - 123,000; Full time

Job summary

GeneDx is seeking a Software Quality Engineer, IVD Quality to support software-specific QMS processes, including SDLC, software risk management, and cybersecurity for IVD and digital products. The role reports to the Director, IVD Regulatory and Quality, collaborating with senior IVD Quality team members.

You will act as the Quality representative on software development and bioinformatics teams, guiding and reviewing to ensure documentation and engineering activities meet QMS, regulatory, and

Qualifications

• Bachelor’s or advanced degree in a relevant scientific or technical field (e.g., Computer Science, Engineering, Bioinformatics).
• 6+ years of software QA experience, with 4+ years in medical device or FDA-regulated software development.
• Experience with design controls and regulations: ISO 13485, ISO 14971, IEC 62304.
• Experience with software as a Medical Device and regulatory submissions/audits.
• Ability to manage multiple projects in a fast-paced environment.

Responsibilities

• Execute assigned software-development Quality activities and support the build-out of SDLC QMS processes.
• Provide Quality reviews and process oversight for software design-control activities (requirements, architecture, code-review, V&V) for compliance and audit readiness.
• Develop and review Design and Development File documentation across the product lifecycle.
• Serve as Quality representative for software risk-management throughout the lifecycle.
• Provide Quality support for validation of non-product software tools used in operations, product testing, and the quality system.
• Support investigations and resolutions of software-related nonconformances, deviations, and CAPAs.
• Provide Quality input on cybersecurity design-control, risk-management, vulnerability-management, and post-market activities per FDA guidance.

Skills

Software QA experience

Regulatory knowledge

Multitask management

Remote work discipline

Education

Bachelor's or higher in CS/Engineering/Bioinformatics

CSQE certification preferred

Job description

GeneDx is seeking a Software Quality Engineer, IVD Quality to support software-specific QMS processes, including SDLC, software risk management, and cybersecurity for IVD and digital products. The role reports to the Director, IVD Regulatory and Quality, collaborating with senior IVD Quality team members.

You will act as the Quality representative on software development and bioinformatics teams, guiding and reviewing to ensure documentation and engineering activities meet QMS, regulatory, and