Quality Control Supervisor, Instruments (Medical Devices)

TL;DR

Quality Control Supervisor, Instruments (Medical Devices): Leading incoming inspection processes for diagnostic instruments with an accent on FDA, ISO, and GMP compliance. Focus on supervising personnel, implementing Lean Manufacturing, and managing NCMRs to ensure product quality and regulatory adherence.

Location: Austin, Texas, United States (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

• Supervise incoming inspection personnel and manage resources to meet company and regulatory goals.
• Ensure strict adherence to Safety, Quality, GMP, ISO, and housekeeping standards.
• Implement Lean Manufacturing and provide technical support to increase productivity and reduce costs.
• Oversee supplier quality metrics and analyze data to develop corrective actions.
• Manage NCMRs, including investigation, testing, disposition, and ERP inventory reconciliation.
• Develop and improve controls for incoming inspections for new and existing products.

Requirements

• Bachelor's Degree in Life Science or Engineering.
• Must be based in or have work authorization for the United States (Austin, Texas).
• 5+ years of experience in hardware manufacturing within an FDA regulated or ISO certified environment.
• 2+ years of leadership experience in Manufacturing Operations.

Culture & Benefits

• Competitive salary and comprehensive benefits package.
• People-centered culture valuing accountability, inclusion, and continuous development.
• Entrepreneurial environment enabling speed, collaboration, and global impact.