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Diasorin · 2 days ago

QA Engineer

Austin, TX

Full-time

Onsite

Entry, Mid Level

2+ 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 QA Engineer will be responsible for evaluating and optimizing manufacturing and CAPA processes to improve product consistency, ensure regulatory compliance, and increase productivity.

BiotechnologyHealth Diagnostics

H1B Sponsor Likely

Responsibilities

Review of design, manufacturing, purchasing, and test documentation to ensure quality requirements are fulfilled

Review specifications, operation instructions, sheets, process procedures, test procedures, inspection and test analysis

Provide leadership in and employ advanced quality planning techniques (FMEA, Capability Studies, Measuring and Test Equipment Studies, Product Validation and Reliability Test)

Assist in determining process/equipment capabilities

Assist in the development of process flow diagrams and perform gap analyses on current controls versus required controls

Investigate the root cause of external and internal non-conforming products

Drive corrective and preventive actions and verifications of effectiveness such as actions for customer complaints, internal audits, and internal and external suppliers non-conformance

Perform assessments of process-related risks, bridging the gap between technical quality requirements and business goals to support strategic decision-making

Assist in the development of inspection procedures and justified sample plans

Develop and maintain systems to collect, analyze, and report data reflecting status of product and process and provide recommendation to improve

Represent quality on new product development teams for design transfer with guidance from more senior quality engineers or management

Apply project management principles to lead continuous improvement and Lean initiatives

Perform other duties as assigned

Qualification

Process ValidationStatistical Quality ControlFDA RegulationsAdvanced SPCQuality Analysis ToolsCorrective Action ProcessData AnalysisProject ManagementTechnical WritingProblem Solving

Required

Bachelor's Degree and/or equivalent experience in a Life Sciences discipline (Biochemistry, Chemistry, Microbiology, etc.) or Engineering discipline (Mechanical, Electrical or Industrial Engineering)

2+ Years related experience in IVD, medical, pharmaceutical, or other related industry

Proven experience in Process, Product, and/or Method Validation is required

Must have a thorough understanding of statistical quality control, statistical process control, Corrective Action Process, and their application manufacturing as a problem identification and resolution tool

Proficient in Advanced SPC, Quality Analysis Tools (Taguchi, Fishbone) & DOE

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations

Ability to write reports, business correspondence, and procedure manuals

Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public

Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis

Ability to define problems, collect data, establish facts, and draw valid conclusions

Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables

Preferred

ASQ Certified Quality Engineer preferred

FDA Process Validation Techniques 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

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2025 (1)

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