Remote IVD Quality Engineer - Supplier & Post-Market

GeneDx, Inc; Northern (KY); Hybrid; USD 85,000 - 93,000; Full time

Benefits offered by this job

Fully remote position

Job summary

GeneDx, Inc. is seeking a Quality Engineer, IVD Quality, to support supplier‑quality and post‑market processes for IVD products.

You will partner with Procurement and Quality leadership to manage supplier qualification, audits, change assessments, and CAPA activities, ensuring regulatory compliance and quality across the supply chain. The role requires 3+ years in quality engineering/assurance within regulated environments, including IVD or medical devices, and hands‑on experience with audits,

Qualifications

• 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 elevate issues appropriately.

Responsibilities

• Support established IVD supplier‑quality and post‑market processes.
• Collaborate with Procurement to support supplier onboarding and performance management.
• Conduct or support supplier audits and track corrective actions.
• Evaluate changes and quality events for impact on product quality or regulatory status.
• Assist supplier readiness during design transfer.
• Carry out post‑market activities: complaint intake, deviations, CAPAs, investigations.
• Investigate supplier quality events and assess supplier contributions to issues.
• Compile supplier and post‑market metrics for trend reporting.
• Draft and maintain supplier‑quality procedures and records.
• Support audit/inspection readiness.
• Identify process gaps and propose QMS improvements.

Skills

Quality Engineering

Supplier quality

Quality Assurance

Audits & Assessments

Education

Bachelor’s degree in a scientific, engineering, technical, or related discipline

Job description

GeneDx, Inc. is seeking a Quality Engineer, IVD Quality, to support supplier‑quality and post‑market processes for IVD products.

You will partner with Procurement and Quality leadership to manage supplier qualification, audits, change assessments, and CAPA activities, ensuring regulatory compliance and quality across the supply chain. The role requires 3+ years in quality engineering/assurance within regulated environments, including IVD or medical devices, and hands‑on experience with audits,