Software Quality Engineer

🕒 September 2

🇺🇸 United States – Remote

💵 $111.2k - $122.6k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 27%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Open for 73 days.
• Jobs at this company usually fill in 30 days.
• Reposted once.

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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 development, implementation, and maintenance of software-specific QMS processes, including SDLC, Software Risk Management, and Cybersecurity • Serve as 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 throughout the software lifecycle • Support validation of non-product software tools used in operations, product testing, and the quality system • 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 responses to findings • Monitor evolving FDA and international regulatory expectations, standards, and best practices for software in IVDs • Recommend updates to applicable processes and documentation • Contribute to continuous improvement initiatives related to software development and quality processes • Report to the Director, IVD Regulatory and Quality and partner with senior IVD Quality team members

🎯 Requirements

• Bachelor’s or advanced degree in a relevant scientific or technical field, such as Computer Science, Engineering, or Bioinformatics • 6+ years of software QA experience • 4+ years of experience 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 • Reliable high-speed internet access • Availability for Monday through Friday, 9 AM to 5 PM EST

🏖️ Benefits

• Competitive compensation and benefits reflecting local market practices and legal requirements • Fully remote work from a home office or other suitable remote location • Flexible standard work schedule established with the leader and adjustable to business needs • Standard office equipment including computer, phone, and video conferencing tools

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