QA Technician

DiaSorin; Austin (TX); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Health benefits

401(k) retirement plan

Annual incentive program

Job summary

Diasorin in Austin, TX is seeking a Quality Assurance Technician I to ensure Device History Records compliance with FDA and ISO standards, support release of materials and finished devices, and drive continuous improvement.

The role requires an Associate degree in life sciences or engineering, 1+ year in FDA-regulated manufacturing, and strong documentation skills. We offer health benefits, retirement plans, time off, and growth opportunities.

Qualifications

• Associate degree in life science or engineering or equivalent.
• HS diploma required.
• Minimum 1 year experience in FDA-regulated manufacturing.
• Experience with participating in formal audits preferred.
• Quality certifications such as CQT, CQI, or CCT are preferred.

Responsibilities

• Review DHRs and other QA records for completeness, accuracy, and compliance with procedures; execute product release.
• Verify production, inspection, and test documentation meets release criteria.
• Identify and document discrepancies or non-conformances; generate NCs as needed.
• Log, file, maintain, and archive QA reports and records.
• Maintain and track key performance metrics; support QA data needs.
• Perform QA Gemba walkthroughs to drive continuous improvement and compliance.

Skills

Verbal & written communication

Computer skills

Organizational/time management

Deadline pressure handling

Oracle familiarity

Education

Associate's Degree in life science or engineering

High School Diploma

FDA-regulated manufacturing/audits experience

Quality certifications (CQT/CQI/CCT) preferred

Tools

Oracle

Job description

Obsessed by Science. Entrepreneurial by Nature. United by Purpose.

Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide. For more than 50 years, we have combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions.

As the Diagnostics Specialist, Diasorin continuously invests in research, technology, and people. Guided by our values of operational excellence, customer focus, and teamwork, we empower teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry's broadest specialty diagnostic portfolios.

When you join Diasorin, you are not just filling a role. You are helping build what comes next.

Why Join Diasorin

• Build What Matters
  Take ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide.


• Innovate with Agility at a Global Scale
  Work in an entrepreneurial environment that enables speed, collaboration, and global impact.


• Grow in a People-Centered Culture
  Thrive in a culture that values accountability, inclusion, and continuous development.

Job Scope

The Quality Assurance Technician I is responsible for reviewing and verifying Device History Records (DHRs) toensure compliance with internal procedures, FDA regulations (21 CFR Part 820), and ISO standards (e.g., ISO13485). This role supports the release of intermediate materials and finished medical devices and ensuresproduct quality and regulatory compliance.

Key Duties and Responsibilities

• Review completed Device History Records (DHRs) and other quality records for completeness, accuracy, and compliance with documented procedures and execute product release under a production schedule


• Verify that all required production, inspection, and test documentation is complete and meets release criteria


• Identify and document any discrepancies or non-conformances found during DHR review, generating Non-Conformance Reports (NCs) as needed


• Log, file, maintain and archive various QA reports & records


• Maintain and track key performance metrics


• Perform QA Gemba walkthroughs of manufacturing operations to drive continuous improvement and compliance


• Assist in continuous improvement of DHR review processes and related quality procedures


• Participate in quality investigations (e.g., CAPA, NCs) related to DHR errors or product quality issues as needed


• Assist other Quality Assurance personnel in data collection as needed


• Other duties as assigned

Education, Experience, and Qualifications

• Associate's Degree Associate degree in a life science or engineering or equivalent related experience Preferred Or


• H.S. Diploma Required


• Minimum Years of Experience


• 1+ Years Experience in FDA regulated manufacturing environment, previous Quality experience Preferred


• 1+ Years Experience with participating in formal audits preferred Preferred


• Certification in a quality discipline preferred, such as CQT, CCT, CQI, etc. Preferred

Training and Skills

• Good verbal and written communication skills


• Computer skills (Microsoft Windows and Office programs), familiarity with Oracle preferred


• Highly organized with proven time management and prioritization skills


• Ability to handle the pressure of meeting tight deadlines

What we offer

Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial well-being, time off programs, well-being support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance.

Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers. We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide.

Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable law.

This posting and recruitment process are subject to applicable local laws and regulations in the country where the position is located. Additional employment disclosures, candidate rights, and employment conditions may apply based on local jurisdiction.

Individuals hired will be required to verify identity and eligibility to work and may be subject to a background check and drug screening where permitted by law. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities during the application process. If assistance is required, please contact [e-mail].