QA Engineer (Medical Devices)

TL;DR

QA Engineer (Medical Devices): Evaluating and optimizing manufacturing and CAPA processes for immunodiagnostic and molecular diagnostic solutions with an accent on regulatory compliance and product consistency. Focus on end-to-end validation lifecycles, root cause investigation of non-conforming products, and implementing Lean initiatives.

Location: Austin, Texas, USA (Onsite)

Company

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

What you will do

• Review design, manufacturing, purchasing, and test documentation to ensure all quality requirements are fulfilled.
• Employ advanced quality planning techniques including FMEA, Capability Studies, and Product Validation.
• Investigate root causes of internal and external non-conforming products and drive corrective and preventive actions (CAPA).
• Perform process-related risk assessments to bridge the gap between technical quality requirements and business goals.
• Develop and maintain data collection systems to analyze and report on the status of products and processes.
• Apply project management principles to lead continuous improvement and Lean initiatives.

Requirements

• Bachelor's Degree in a Life Sciences discipline (Biochemistry, Chemistry, Microbiology) or Engineering (Mechanical, Electrical, or Industrial).
• 2+ years of related experience in IVD, medical, pharmaceutical, or other related industries.
• Proven experience in Process, Product, and/or Method Validation.
• Thorough understanding of statistical quality control (SPC) and Corrective Action Processes.
• Proficiency in Quality Analysis Tools (Taguchi, Fishbone) and Design of Experiments (DOE).
• Must be based in or authorized to work in Austin, Texas.

Nice to have

• ASQ Certified Quality Engineer certification.
• Experience with FDA Process Validation Techniques.

Culture & Benefits

• Entrepreneurial environment that enables speed, collaboration, and global impact.
• People-centered culture focusing on accountability, inclusion, and continuous development.
• Opportunity to take ownership and contribute directly to solutions that improve patient care globally.
• Commitment to diversity and equal opportunity employment.