Quality Engineer

Summary  

• The Quality Engineer, IVD Quality supports the implementation, maintenance, and execution of supplier-quality and post-market Quality processes for GeneDx’s IVD and software-enabled IVD products. The role reports to the Director, IVD Regulatory and Quality and works in close partnership with senior members of the IVD Quality team. 

• This hands-on role is initially focused on supplier quality, including supplier qualification, monitoring, change management, performance monitoring, and supplier-related investigations. The role also executes assigned post-market Quality activities, including complaint handling, nonconformance and deviation management, CAPA support, investigations, and Quality trend reporting. 

Job Responsibilities 

• Support implementation, maintenance, and continuous improvement of established IVD supplier-quality and post-market quality processes. 

• Partner with Procurement and other applicable stakeholders to support 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 potential impact on product quality, supply continuity, or regulatory status; escalate complex or high-risk assessments as appropriate. 

• Support supplier readiness during design transfer by confirming supplier qualification status, required documentation, and applicable process controls. 

• Execute assigned 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 whether supplier materials, reagents, software, services, or performance may have contributed to a complaint, deviation, nonconformance, or other post-market event. 

• Compile supplier and post-market quality metrics and 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, following established QMS standards. 

• Support audit and inspection readiness by organizing objective evidence and responding to requests under the direction of Quality leadership. 

• Identify process gaps and improvement opportunities within assigned processes and escalate recommendations for broader QMS changes. 

Education, Experience, and Skills 

• 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. 

Certificates, Licenses, Registrations  

• ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Engineer (CQE), ISO 13485 Internal Auditor, and/or ISO 13485 Lead Auditor certification preferred.  

Work Environment  

• This is a fully remote position. The employee will work from a home office or other suitable remote location with reliable high-speed internet access. Work is performed in a climate-controlled environment using standard office equipment including computer, phone, and video conferencing tools. Your standard work schedule and hours will be established in collaboration with your leader and may be adjusted to align with evolving business needs. 

• Standard work hours are Monday through Friday, 9 AM to 5 PM EST. 

• Ability to travel up to 20% of the time, including occasional domestic and international travel, to conduct supplier audits and support supplier qualification activities. 

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