Quality Engineer

🔥 16 hours ago

🇺🇸 United States – Remote

💵 $84.9k - $93.2k / 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 implementation, maintenance, and continuous improvement of established IVD supplier-quality and post-market quality processes. • Partner with Procurement and stakeholders on supplier onboarding, risk classification, qualification, change management, monitoring, and performance management. • Maintain supplier qualification records, Quality Agreements, and the Approved Supplier List. • Conduct or support supplier audits and assessments; prepare audit reports and track supplier corrective actions to closure. • Evaluate supplier-initiated changes and quality events for impacts on product quality, supply continuity, or regulatory status; escalate complex or high-risk assessments. • Support supplier readiness during design transfer by confirming qualification status, documentation, and process controls. • Execute post-market quality activities, including complaint intake and investigation support, nonconformances, deviations, CAPAs, quality-event documentation, action tracking, and effectiveness checks. • Investigate supplier-related quality events and assess supplier contributions to complaints, deviations, nonconformances, or other post-market events. • Compile supplier and post-market quality metrics; support trend reporting, management review, and quality-governance activities. • Draft and maintain supplier-quality and post-market quality procedures, work instructions, forms, templates, and quality records under established QMS standards. • Support audit and inspection readiness by organizing objective evidence and responding to requests under Quality leadership. • Identify process gaps and improvement opportunities and escalate recommendations for broader QMS changes.

🎯 Requirements

• Bachelor’s degree in a scientific, engineering, technical, or related discipline. • Minimum of 3 years of Quality Engineering, Quality Assurance, supplier quality, or related experience, including at least 2 years within an IVD, molecular diagnostics, medical-device, or similarly regulated environment. • Experience with supplier qualification, supplier monitoring, quality agreements, supplier corrective actions, supplier change assessments, and supplier performance monitoring. • Experience supporting at least one post-market quality process, such as complaint handling, nonconformance management, deviation management, CAPA, investigations, or quality trending. • Working knowledge of applicable FDA quality-system requirements, ISO 13485, and ISO 14971. • Experience conducting or supporting supplier audits and assessments. • Working knowledge of product development, design transfer, and supplier readiness activities. • Ability to execute defined quality processes, manage multiple priorities, and escalate issues appropriately. • ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Engineer (CQE), ISO 13485 Internal Auditor, and/or ISO 13485 Lead Auditor certification preferred. • Reliable high-speed internet access.

🏖️ Benefits

• Competitive compensation and benefits reflecting local market practices and legal requirements in each country where GeneDx operates