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Diasorin · 2 weeks ago

Senior QA Technician

Austin, TX

Full-time

Onsite

Mid, Senior Level

3+ years exp

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. The Sr. Quality Assurance Technician is responsible for reviewing and verifying Device History Records to ensure compliance with internal procedures and regulations, supporting product quality and regulatory compliance.

BiotechnologyHealth Diagnostics

H1B Sponsor Likely

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

Qualification

FDA regulationsISO 13485GMP knowledgeOracle familiarityQuality Assurance experienceCommunication skillsAttention to detailTime management

Required

H.S. Diploma or equivalent required

3+ Years Experience in FDA regulated manufacturing environment, previous Quality experience 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)

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

Preferred

Associate's Degree in a life science or engineering or equivalent related experience preferred

3+ Years Experience with participating in formal audits preferred

Familiarity with Oracle preferred

Company

Diasorin

Glassdoor3.1

DiaSorin is an Italian multinational Group and a global leader in the market for in vitro diagnostics

Founded in 1968

Saluggia, Piemonte, ITA

1001-5000 employees

https://www.diasorin.com/

H1B Sponsorship

Diasorin has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)

2022 (1)