Senior QA Technician

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Published on:
Nov 30, 2025

Country:
United States

Location:

Austin, Texas

Company:
Luminex Corporation

Job Category:
Quality

Employment type:

Regular Full Time

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting‑edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world. Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."

Why Join Diasorin? Impactful Work:
When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world. Global Reach &

Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry. Diverse and Inclusive Culture:
We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive. Join Our Team:
If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward. Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare.

Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!

Job Scope

The Sr. Quality Assurance Technician is responsible for reviewing and verifying Device History Records (DHRs) to ensure compliance with internal procedures, FDA regulations (21 CFR Part 820), and ISO standards (e.g., ISO 13485). This role supports the release of intermediate materials and finished medical devices and ensures product quality and regulatory compliance.

Job Responsibilities

• Inspect and verify product labels and insert, perform data review for material intermediate and component releases, label reconciliation in DHR, complete release documentation (release forms and status labels)
• Conduct review of documentation in accordance with released procedures, GxP standards (GDP, GMP) and production schedules
• Verify that all required production, inspection, and test documentation is complete and meets release criteria, including raw material status, calibration, etc.
• Attend interdepartmental meetings to support and coordinate product release, such as MRB.
• 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 and assist other Quality Assurance personnel in data collection as needed
• Perform quality walkthroughs of manufacturing operations to drive continuous improvement and compliance
• Assist in continuous improvement of DHR review and related quality processes
• Participate in quality investigations (e.g., CAPA, NCs) related to DHR errors or product quality issues as needed
• Provide support during external audits and regulatory inspections,
• Other duties as assigned

Education, Experience and Qualifications

• H.S. Diploma or equivalent required
• Associate's Degree in a life science or engineering or equivalent related experience preferred
• 3+ Years Experience in FDA regulated manufacturing environment, previous Quality experience preferred
• 3+ Years Experience with participating in formal audits preferred
• Good verbal and written communication skills in the English…