Senior Quality Engineer

🔥 17 hours ago

🇺🇸 United States – Remote

💵 $131k - $145.1k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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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 product-development QMS processes for GeneDx’s IVD and software-enabled IVD products • Execute assigned IVD QMS and product-development activities and maintain lifecycle-process compliance • Draft, revise, route, approve, and maintain SOPs, work instructions, forms, templates, and other controlled QMS documentation • Serve as Quality representative on assigned product core teams and cross-functional working groups • Provide Quality review and guidance, identify quality-system gaps, and escalate significant Quality, compliance, product-safety, and risk-based issues • Support design-control processes, including design plans, inputs and outputs, reviews, traceability, verification and validation, design transfer, and design-history-file records • Facilitate and review risk-management plans, assessments, controls, residual-risk documentation, and traceability • Support change control, nonconformance, deviation, CAPA, complaint handling, and post-market quality processes • Support internal and external audits and inspection readiness, including evidence preparation, corrective-action tracking, and responses to observations • Compile and analyze Quality metrics for governance and management review • Identify process gaps, compliance risks, and improvement opportunities and implement risk-based solutions • Support supplier-quality activities, including supplier documentation, design-transfer readiness, change assessments, and corrective-action follow-up • Promote quality, accountability, continuous improvement, and cross-functional collaboration

🎯 Requirements

• A bachelor’s or advanced degree in a scientific, engineering, technical, or related discipline (e.g., Biology, Chemistry, Biomedical Engineering, Medical Technology) • Minimum of 6 years of Quality Engineering or Quality Assurance experience • At least 4 years specifically within an IVD, molecular diagnostics, or medical device regulated environment • Practical experience applying FDA quality-system requirements, ISO 13485, ISO 14971, IEC 62304, and IEC 62366, as applicable • Expertise in technical writing and QMS development • Experience drafting, revising, and implementing SOPs, work instructions, and quality templates • Strong understanding of the product development lifecycle • Experience serving on cross-functional core teams • Experience supporting regulatory submissions and audits/inspections • Ability to manage multiple projects and priorities in a fast-paced environment • Ketryx or similar connected lifecycle management and automated compliance tools experience is a plus • ASQ CQA, ASQ CQE, ISO 13485 Internal Auditor, and/or ISO 13485 Lead Auditor certification preferred

🏖️ Benefits

• Competitive compensation • Benefits reflecting local market practices and legal requirements in each country where GeneDx operates • Fully remote work from a home office or other suitable remote location • Monday–Friday, 9 AM–5 PM EST schedule • Standard office equipment including computer, phone, and video conferencing tools