Quality Assurance Director (Medtech)

TL;DR

Quality Assurance Director (Medtech): Leading and maintaining the Quality Management System (QMS) for the molecular business unit with an accent on regulatory compliance (FDA, ISO 13485, IVDR) and operational quality. Focus on driving process improvements through lean manufacturing, managing regulatory audits, and overseeing CAPA and risk management.

Location: Northbrook, Illinois, USA (Chicago site)

Salary: $151,200 - $216,000 annually

Company

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

What you will do

• Manage and continuously improve the QMS aligned with lean manufacturing principles to support product quality and operational efficiency.
• Serve as the primary point of contact for regulatory inspections and audits, proactively addressing compliance gaps.
• Perform expert-level technical analysis of product development and manufacturing processes to ensure conformance to specifications.
• Mentor and develop junior Quality Engineers, fostering a culture of accountability and continuous improvement.
• Lead the execution of Corrective and Preventive Actions (CAPA) using root cause analysis and data-driven risk mitigation.
• Oversee validation planning and execution for manufacturing processes, equipment, and software.

Requirements

• Bachelor's degree in Engineering or Life Sciences (Mechanical, Electrical, Industrial, Bioengineering, etc.); Master's preferred.
• Minimum 7+ years of management experience in the medical device industry, including IVD experience.
• 5+ years of experience specifically in quality management.
• Thorough knowledge of FDA regulations and ISO 13485 Quality Management Systems.
• Proficiency in software lifecycle and validation requirements.
• Must be authorized to work in the United States.

Nice to have

• ASQ Certified Quality Engineer.
• Lean Six Sigma Black Belt.
• Certified Quality or Biomedical Auditor.

Culture & Benefits

• Competitive salary and comprehensive health benefits package.
• Retirement and financial well-being programs.
• Time off programs and well-being support.
• People-centered culture valuing accountability, inclusion, and continuous development.
• Opportunity to work in an entrepreneurial environment with global impact on patient care.