Quality Engineer II (Medtech)

TL;DR

Quality Engineer II (Medtech): Supporting and maintaining quality assurance activities within an In Vitro Diagnostics (IVD) manufacturing environment with an accent on regulatory compliance and process validation. Focus on executing IQ/OQ/PQ protocols, leading root cause analysis, and ensuring adherence to FDA and ISO 13485 standards.

Location: Onsite in Austin, Texas, USA

Company

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

What you will do

• Execute quality engineering tasks to support manufacturing operations.
• Write and review validation protocols, including IQ, OQ, PQ, and TMV.
• Support design transfer and risk management activities to ensure product quality.
• Lead problem-solving initiatives using root cause analysis methodologies.
• Participate in internal audits to maintain compliance with global regulatory standards.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• 3-6 years of quality assurance or manufacturing experience in a relevant industry.
• Working knowledge of quality systems within the IVD sector.
• Familiarity with ISO 13485 and FDA QSR (21 CFR Part 820).
• Experience in process validation and test method validation.
• Must be based in or able to work onsite in Austin, Texas.

Nice to have

• Certification in quality disciplines such as ASQ Certified Quality Engineer (CQE), Quality Auditor (CQA), or Six Sigma Black Belt.

Culture & Benefits

• Entrepreneurial environment that enables speed, collaboration, and global impact.
• People-centered culture valuing accountability, inclusion, and continuous development.
• Opportunity to take ownership and contribute directly to solutions improving global patient care.
• Commitment to a diverse and empowering workplace.