Quality Engineer (IVD)

Location: Fully remote; standard working hours are Monday through Friday, 9 AM to 5 PM EST. Travel of up to 20% may be required, including occasional domestic and international supplier-audit travel.

Salary: $84,871–$93,166 USD per year

Company

hirify.global develops and supports genomic and diagnostic solutions designed to help patients receive diagnoses earlier.

What you will do

• Implement, maintain, and improve IVD supplier-quality and post-market quality processes.
• Support supplier onboarding, risk classification, qualification, change management, monitoring, and performance management.
• Conduct or support supplier audits, prepare reports, and track supplier corrective actions to closure.
• Execute post-market activities including complaint handling, nonconformances, deviations, CAPAs, investigations, and effectiveness checks.
• Investigate supplier-related quality events and assess their impact on product quality, supply continuity, and regulatory status.
• Compile quality metrics, maintain QMS documentation, support audits and inspections, and identify process improvements.

Requirements

• Bachelor’s degree in a scientific, engineering, technical, or related discipline.
• At least 3 years of Quality Engineering, Quality Assurance, supplier-quality, or related experience, including 2 years in IVD, molecular diagnostics, medical devices, or a similarly regulated environment.
• Experience with supplier qualification, monitoring, quality agreements, corrective actions, change assessments, and 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 FDA quality-system requirements, ISO 13485, and ISO 14971, plus experience with supplier audits and assessments.
• Working knowledge of product development, design transfer, supplier readiness, and defined quality-process execution.

Nice to have

• ASQ Certified Quality Auditor, ASQ Certified Quality Engineer, ISO 13485 Internal Auditor, or ISO 13485 Lead Auditor certification.

Culture & Benefits

• Fully remote work from a home office or another suitable remote location.
• Competitive compensation and benefits aligned with local market practices and legal requirements in each operating country.
• Culture emphasizing ownership, high standards, teamwork, initiative, continuous improvement, and meaningful patient impact.
• Occasional domestic and international travel to support supplier audits and qualification activities.