Remote IVD Quality Engineer – Supplier & Post-Market

GeneDx; United States; On-site; USD 85,000 - 93,000; Full time

Job summary

GeneDx is seeking a Quality Engineer, IVD Quality to join our fully remote team in the United States. You will lead supplier-quality and post-market quality processes, partnering with Procurement to onboard suppliers, monitor performance, and support CAPA and quality investigations.

You will have 3+ years in quality engineering within regulated environments, plus a Bachelor’s degree and ASQ certifications preferred. Willingness to travel up to 20% is required.

Qualifications

• 3+ years of Quality Engineering or supplier quality in regulated environments.
• Experience with supplier qualification, monitoring and performance management.
• Experience supporting post-market processes: complaint handling, deviations, CAPA.
• Knowledge of FDA QSR, ISO 13485 and ISO 14971.
• Experience conducting or supporting supplier audits and assessments.

Responsibilities

• Support implementation, maintenance, and improvement of IVD supplier-quality and post-market processes.
• Partner with Procurement to support supplier onboarding, qualification, monitoring, and performance management; maintain records.
• Conduct or support supplier audits; prepare audit reports and track CAPAs to closure.
• Evaluate supplier-initiated changes and quality events for impact on product quality or regulatory status.
• Support supplier readiness during design transfer with qualification status and required documentation.
• Execute post-market quality activities including complaint intake, investigation support, nonconformances, deviations, CAPAs, and trend reporting.
• Investigate supplier-related quality events and assess supplier materials or services contributions.
• Compile supplier and post-market quality metrics and support governance activities.
• Draft and maintain supplier-quality procedures, work instructions, and quality records per QMS.
• Support audit and inspection readiness and identify opportunities for QMS improvements.

Skills

supplier qualification

supplier monitoring

supplier audits

quality agreements

CAPA

post-market quality

FDA QSR

ISO 13485

ISO 14971

design transfer

Education

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

ASQ Certified Quality Auditor (CQA)

ASQ Certified Quality Engineer (CQE)

ISO 13485 Internal Auditor

ISO 13485 Lead Auditor

Job description

GeneDx is seeking a Quality Engineer, IVD Quality to join our fully remote team in the United States. You will lead supplier-quality and post-market quality processes, partnering with Procurement to onboard suppliers, monitor performance, and support CAPA and quality investigations.

You will have 3+ years in quality engineering within regulated environments, plus a Bachelor’s degree and ASQ certifications preferred. Willingness to travel up to 20% is required.