Senior QA Technician

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  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.
  

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  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.
  

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 language
• Ability to interpret a variety of instructions in written 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

Standard Physical Demands

• Vision (Color) on the job is required - Occasionally

Standard Working Conditions

• Must work onsite at Luminex office - Constantly
• Work is normally performed in an office and a manufacturing environment - Constantly
• Possible exposure to biological or chemical hazard, 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

Travel Requirements

• 10% Domestic travel may be required