Senior Quality Engineer (Medtech)

TL;DR

Senior Quality Engineer (Medtech): Leading quality engineering activities for IVD product manufacturing with an accent on quality system development, validation, and regulatory compliance. Focus on managing manufacturing transfers, performing root cause analysis for CAPAs, and ensuring adherence to FDA and ISO standards.

Location: Austin, Texas, United States

Company

hirify.global is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide.

What you will do

• Lead Quality Engineering activities supporting IVD product manufacturing and associated processes.
• Provide QA oversight for manufacturing transfers and replication of operations from contract manufacturers to internal facilities.
• Review and approve validation and qualification activities including IQ, OQ, PQ for processes, equipment, and software.
• Lead investigations into nonconformances, deviations, and CAPAs, ensuring effective root cause analysis.
• Provide quality oversight for risk management, design controls, and PFMEAs.
• Support internal audits, supplier audits, and regulatory inspections to ensure compliance.

Requirements

• Bachelor's degree in a life science or engineering discipline.
• 7+ years of Quality Engineering or QA experience in medical device, IVD, or pharmaceutical regulated manufacturing.
• Strong knowledge of FDA 21 CFR 820, ISO 13485, IVDR, and ISO 14971.
• Expertise in validation, risk management, and CAPA.
• Proven ability to independently lead complex quality initiatives and mentor other team members.
• Ability to travel approximately 10%.

Nice to have

• ASQ certifications such as CQE or CQA.

Culture & Benefits

• Competitive salary and comprehensive benefits package.
• Entrepreneurial environment that enables speed, collaboration, and global impact.
• People-centered culture valuing accountability, inclusion, and continuous development.
• Opportunity to take ownership and directly contribute to solutions improving patient care.