QA Technician II (Medical Devices)

TL;DR

QA Technician II (MedTech): Performing detailed review and approval of Device History Records (DHRs) to ensure compliance with regulatory requirements with an accent on documentation review and discrepancy resolution. Focus on verifying product labels, conducting internal audits, and ensuring timely product release in a GMP environment.

Location: Onsite in Austin, Texas

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 and approve Device History Records (DHRs) to ensure compliance with regulatory requirements and internal procedures.
• Inspect product labels and inserts, and perform data review for material intermediate and component releases.
• Conduct documentation reviews in accordance with released procedures and GxP standards (GDP, GMP).
• Coordinate product release by attending interdepartmental meetings, including the Material Review Board (MRB).
• Perform internal audits and open non-conformances (NCs) in the applicable system.
• Track key performance metrics related to DHR review and create certificates of compliance.

Requirements

• High School Diploma or GED.
• 2-3 years of relevant experience in a Good Manufacturing Practices (GMP) environment.
• Working knowledge of GMP, GDP, and regulatory requirements (FDA, ISO 13485).
• Must be based in Austin, Texas.
• Proficiency in English (reading, speaking, and writing).
• Ability to perform physical tasks, including lifting up to 30 lbs.

Culture & Benefits

• Entrepreneurial environment that enables speed, collaboration, and global impact.
• Culture that values accountability, inclusion, and continuous professional development.
• Opportunity to take ownership and contribute directly to solutions improving patient care.
• Commitment to building a diverse and empowered workplace.