QA Technician (Medtech)

TL;DR

QA Technician (Medtech): Reviewing and verifying Device History Records (DHRs) to ensure compliance with FDA and ISO standards with an accent on quality documentation and regulatory adherence. Focus on identifying non-conformances, supporting product release, and maintaining quality records within a regulated manufacturing environment.

Location: Must be based in Austin, Texas, USA

Salary: $41,638 - $66,621

Company

hirify.global is a global leader in diagnostic solutions, providing a wide range of specialty diagnostic tests and instruments to improve healthcare worldwide.

What you will do

• Review completed Device History Records (DHRs) and quality records for accuracy and compliance.
• Execute product release processes according to production schedules.
• Identify and document discrepancies, generating Non-Conformance Reports (NCs) as needed.
• Maintain and archive quality reports and track key performance metrics.
• Perform QA Gemba walkthroughs of manufacturing operations to ensure continuous compliance.
• Participate in quality investigations including CAPA and NCs.

Requirements

• Must be authorized to work in the United States
• Associate's degree in life science or engineering, or equivalent experience (H.S. Diploma required).
• 1+ years of experience in an FDA-regulated manufacturing environment.
• Familiarity with FDA 21 CFR Part 820 and ISO 13485 standards.
• Proficiency in Microsoft Windows and Office programs.
• Strong organizational, time management, and communication skills.

Nice to have

• Previous quality assurance experience.
• Experience participating in formal audits.
• Quality discipline certifications such as CQT, CCT, or CQI.
• Familiarity with Oracle software.

Culture & Benefits

• Comprehensive health benefits package.
• Retirement and financial well-being programs.
• Time off programs and well-being support.
• Participation in an annual incentive program based on performance.
• Collaborative and inclusive global work environment.