Senior Quality Engineer (IVD Quality)

Location: Fully remote; standard working hours are Monday through Friday, 9 AM to 5 PM EST.

Salary: $131,037–$145,147 USD per year.

Company

hirify.global develops genomic diagnostic solutions to help patients receive diagnoses earlier and live healthier lives.

What you will do

• Execute and maintain IVD quality-management-system and product-development lifecycle activities.
• Draft, revise, route, and maintain SOPs, work instructions, forms, templates, and other controlled QMS documentation.
• Represent Quality on product core teams and cross-functional working groups, identifying process gaps and escalating compliance, safety, and risk issues.
• Support design controls, including design plans, traceability, verification and validation documentation, design transfer, and design-history-file records.
• Facilitate risk management and support change control, nonconformance, deviation, CAPA, complaints, and post-market quality processes.
• Support supplier-quality activities, audits, inspection readiness, quality metrics, management reviews, and continuous improvement initiatives.

Requirements

• Bachelor’s or advanced degree in a scientific, engineering, technical, or related discipline.
• At least 6 years of Quality Engineering or Quality Assurance experience, including 4 years in IVD, molecular diagnostics, or a regulated medical-device environment.
• Practical experience with FDA quality-system requirements, ISO 13485, ISO 14971, IEC 62304, and IEC 62366, as applicable.
• Expertise in technical writing, QMS development, SOPs, work instructions, quality templates, product lifecycle processes, and audit-ready design-history files.
• Experience supporting regulatory submissions, audits, inspections, and multiple concurrent projects.

Nice to have

• Experience with Ketryx or similar connected lifecycle-management and automated-compliance tools.
• ASQ Certified Quality Auditor, ASQ Certified Quality Engineer, ISO 13485 Internal Auditor, or ISO 13485 Lead Auditor certification.

Culture & Benefits

• Mission-driven work focused on improving genomic diagnosis and patient outcomes.
• Culture centered on ownership, high standards, teamwork, continuous improvement, and direct feedback.
• Remote work from a home office or other suitable location with reliable high-speed internet.
• Compensation and benefits reflect local market practices and legal requirements in each operating country.
• Inclusive workplace with equal consideration for qualified applicants.