Principal Quality Engineer (IVD)

Location: Fully remote; standard work hours are Monday through Friday, 9 AM to 5 PM EST. Travel of up to 20% may be required for domestic and international supplier audits and qualification activities.

Salary: $150,458–$168,715 USD annually

Company

hirify.global develops genomics and diagnostic solutions focused on helping patients receive earlier diagnoses.

What you will do

• Lead the implementation roadmap for the IVD quality management system, including priorities, milestones, dependencies, resources, and reporting.
• Establish, maintain, and improve scalable, risk-based QMS processes for IVD and software-enabled IVD products.
• Provide senior Quality oversight in product development, design reviews, risk management, change control, and lifecycle governance.
• Review critical procedures, quality-risk decisions, CAPAs, audit and inspection responses, and management-review outputs.
• Lead QMS metrics, quality objectives, management reviews, audit readiness, inspection support, and CAPA follow-up.
• Oversee supplier-quality strategy and coach Quality personnel supporting IVD product development and supplier activities.

Requirements

• Bachelor’s degree in a scientific, engineering, technical, or related discipline.
• 10+ years of progressive quality assurance or quality systems experience in a regulated environment, including at least 6 years in IVD or medical devices.
• Direct experience implementing or maintaining QMS processes for IVDs, molecular diagnostics, or software-enabled medical devices.
• Working knowledge of FDA quality-system requirements, ISO 13485, ISO 14971, IEC 62304, and IEC 62366.
• Experience with FDA-regulated product development, design controls, risk management, software lifecycle controls, post-market quality, inspections, audits, and regulatory submissions.
• Strong judgment, communication, leadership, and ability to manage complex cross-functional initiatives.

Nice to have

• Advanced degree.
• Experience with Ketryx or similar connected lifecycle-management and automated-compliance tools.
• ASQ CQA and/or ISO 13485 Lead Auditor certification.

Culture & Benefits

• Mission-driven work focused on improving patient diagnosis through genomics.
• Culture emphasizing high standards, ownership, teamwork, initiative, direct feedback, and continuous improvement.
• Fully remote work from a home office or other suitable location with reliable high-speed internet.
• Competitive compensation and benefits aligned with local market practices and legal requirements where hirify.global operates.
• Opportunity to collaborate with Regulatory Affairs, R&D, Software Development, Product, Clinical/Medical Affairs, and Cybersecurity.