Software Quality Engineer

🔥 17 hours ago

🇺🇸 United States – Remote

💵 $111.2k - $122.6k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 0%

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GeneDx

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

🏥 Healthcare

🤖 Artificial Intelligence

Biotechnology • Healthcare • Artificial Intelligence

GeneDx is a biotechnology company dedicated to providing personalized and targeted medical care through genetic diagnosis. Leveraging one of the largest datasets for rare diseases, GeneDx offers advanced testing such as whole genome and exome sequencing. Their diagnostic solutions translate complex genomic information into actionable insights, facilitating personalized health plans, enhancing drug discovery, and improving the efficiency of healthcare systems.

📋 Description

• Support the development, implementation, and maintenance of software-specific QMS processes, including SDLC, Software Risk Management, and Cybersecurity • Serve as the Quality representative on software development and bioinformatics teams • Provide Quality review, guidance, and process support for software engineering activities and technical documentation • Execute assigned software-development Quality activities and support SDLC QMS process development • Oversee software design-control activities, including requirements, architecture documentation, code-review records, and verification and validation documentation • Participate in Design and Development File documentation throughout the product lifecycle • Guide and review software risk-management activities • Support validation of non-product software tools • Investigate and resolve software-related nonconformances, deviations, and CAPAs • Provide Quality input on cybersecurity design control, risk management, vulnerability management, and post-market activities • Support internal and external audits by preparing software-related objective evidence and assisting with findings • Monitor regulatory expectations, standards, and best practices for software in IVDs, recommending process and documentation updates • Contribute to continuous improvement initiatives related to software development and quality processes

🎯 Requirements

• A bachelor’s or advanced degree in a relevant scientific or technical field (e.g., Computer Science, Engineering, Bioinformatics) • 6+ years of software QA experience • 4+ years in medical device or FDA-regulated software development • Practical experience with design controls, ISO 13485, ISO 14971, and IEC 62304 regulations • Experience with Software as a Medical Device or medical devices containing software • Strong understanding of design control procedures and the software development lifecycle in regulated environments • Experience supporting regulatory submissions and audits • Ability to manage multiple projects and priorities in a fast-paced environment • Certified Software Quality Engineer (CSQE) preferred

🏖️ Benefits

• Competitive compensation and benefits reflecting local market practices and legal requirements • Fully remote work from a home office or other suitable remote location • Standard work schedule of Monday through Friday, 9 AM to 5 PM EST