Diagnostics QA Engineer — Validation & Process Excellence

DiaSorin; Austin (TX); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Opportunities for ownership and growth

Innovative and collaborative work environment

Company culture focused on accountability and inclusion

Job summary

DiaSorin, located in Austin, Texas, is seeking a Diagnostics Specialist dedicated to enhancing product quality and compliance in the diagnostics field. This role involves evaluating and optimizing manufacturing processes, ensuring adherence to regulatory requirements, and leading continuous improvement initiatives.

The ideal candidate possesses a Bachelor's Degree in a relevant Life Sciences or Engineering discipline and has over two years of experience in validation processes. Join DiaSorin to make a significant impact in patient care.

Qualifications

• 2+ years of related experience in IVD, medical, or pharmaceutical industries.
• Proven experience in Process, Product, and/or Method Validation.

Responsibilities

• Evaluate and optimize manufacturing and CAPA processes.
• Review design and manufacturing documentation to ensure quality.
• Drive corrective and preventive actions on non-conforming products.

Skills

Statistical quality control

Statistical process control

Corrective Action Process

Advanced SPC

Quality Analysis Tools

Education

Bachelor's Degree in Life Sciences or Engineering discipline

Tools

FMEA

Capability Studies

Product Validation

Job description

DiaSorin, located in Austin, Texas, is seeking a Diagnostics Specialist dedicated to enhancing product quality and compliance in the diagnostics field. This role involves evaluating and optimizing manufacturing processes, ensuring adherence to regulatory requirements, and leading continuous improvement initiatives.

The ideal candidate possesses a Bachelor's Degree in a relevant Life Sciences or Engineering discipline and has over two years of experience in validation processes. Join DiaSorin to make a significant impact in patient care.