Senior QA Technician

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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 over 50 years of experience, we develop innovative diagnostic assays and instruments trusted by healthcare providers around the globe.

• Impactful Work:
  Your contributions directly impact patient care, making a meaningful difference in the world.
• Global Reach & Innovation:
  Collaborate with colleagues worldwide, expanding horizons and contributing to global healthcare solutions at the forefront of the diagnostic industry.
• Diverse and Inclusive Culture:
  We value your unique perspective and offer a supportive, 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.

The Sr. Quality Assurance Technician reviews and verifies 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, ensuring product quality and regulatory compliance.

• Inspect and verify product labels and inserts; perform data review for material intermediate and component releases; reconcile labels in DHR; complete release documentation.
• 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.

• H.S. Diploma or equivalent required.
• Associate's Degree in life science, engineering, or equivalent related experience preferred.
• 3+ Years Experience in FDA‑regulated manufacturing environment; previous Quality experience preferred.
• 3+ Years Experience with formal audits preferred.
• Good verbal and written communication skills in English.
• Ability to interpret a variety of instructions in written or oral form.
• Computer skills (Microsoft Windows and Office programs); familiarity with Oracle preferred.
• Working knowledge of GMP, GDP, and regulatory requirements (FDA, ISO 13485).
• Ability to apply sampling techniques.
• Ability to manage and present data as it relates to product release.
• Highly organized with proven time‑management and prioritization skills.
• Ability to maintain attention to detail in a fast‑paced environment.
• Comfortable with routine work but able to switch back and forth between tasks.

• Vision (Color) on the job is required – Occasionally.

• Must work on‑site at Luminex office – Constantly.
• Work is normally performed in an office and a manufacturing environment – Constantly.
• Possible exposure to biological or chemical hazards, extensive noise, and/or working with lasers – Occasionally.
• Frequent use of personal computer, copiers, printers, and telephones – Frequently.
• Frequent standing, walking, sitting, listening, writing, typing, and talking – Frequently.
• Frequent work under deadlines, and in direct contact with others – Frequently.
• Occasional lifting of 30 lbs. and climbing – Occasionally.

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