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