Diagnostics Quality Engineer: Process & Validation

DiaSorin; Town of Texas (WI); On-site; USD 85,000 - 120,000; Full time

Job summary

DiaSorin is seeking a Diagnostics Specialist to strengthen manufacturing quality and validation processes. The role emphasizes end-to-end validation lifecycles, CAPA leadership, and strong alignment with FDA and ISO13485 requirements.

You will collaborate with cross-functional teams to ensure product consistency and regulatory compliance. The ideal candidate has a life sciences or engineering background with 2+ years in IVD/medical sectors and hands-on validation experience, joining a global

Qualifications

• Bachelor's degree in Life Sciences or Engineering required.
• 2+ years' experience in IVD/medical/pharma industry.
• Proven experience in Process, Product, and/or Method Validation.

Responsibilities

• Review design, manufacturing, purchasing, and test documentation for quality.
• Lead CAPA, FMEA, and other quality planning techniques.
• Support regulatory compliance with FDA and ISO13485.
• Develop process flow diagrams and gap analyses.
• Investigate root causes of non-conforming products.
• Drive corrective actions and verify effectiveness.

Skills

Statistical quality control

Statistical process control

Corrective Action Process

DOE

Education

Bachelor's Degree in Life Sciences or Engineering

Tools

FMEA

Quality Analysis Tools

SPC software

Job description

DiaSorin is seeking a Diagnostics Specialist to strengthen manufacturing quality and validation processes. The role emphasizes end-to-end validation lifecycles, CAPA leadership, and strong alignment with FDA and ISO13485 requirements.

You will collaborate with cross-functional teams to ensure product consistency and regulatory compliance. The ideal candidate has a life sciences or engineering background with 2+ years in IVD/medical sectors and hands-on validation experience, joining a global