MedTech Quality Engineer – Process & CAPA Lead

DiaSorin; Stillwater (MN); On-site; USD 75,000 - 93,000; Full time

Job summary

DiaSorin Inc in Stillwater, MN seeks a Quality Engineer to serve as a QA expert in process controls, validation, CAPA and risk management. You will partner with manufacturing, supply chain and development to ensure compliant product quality and robust processes.

The role emphasizes Design Control, MDR/IVDR readiness, data analysis and internal/external audits, with a focus on continuous improvement and Lean initiatives across the QMS.

Qualifications

• Bachelor's Degree in Engineering, Life Sciences or related field.
• 3+ years quality engineer experience in medical device or regulated industry.
• FDA QSR and ISO 13485, 9001 & 14971 and MDSAP Compliance.
• CAPA and Root Cause Analysis.
• Quality Auditing and Change Control.
• Design and New Product Development and Process Validation.

Responsibilities

• Provide QA representation and advisement within cross-functional teams.
• Lead CAPA, NCR and risk management activities.
• Review design controls and development processes for compliance.
• Support internal and external audits of the QMS.
• Drive continual improvement of product quality and processes.

Skills

CAPA

Root Cause Analysis

Regulatory compliance

Statistics

Process Validation

Design Control

QMS software

MS Word

PowerPoint

Six Sigma

Education

Bachelor's Degree in Engineering / Life Sciences

Tools

MS Word

PowerPoint

Excel

QMS software

Job description

DiaSorin Inc in Stillwater, MN seeks a Quality Engineer to serve as a QA expert in process controls, validation, CAPA and risk management. You will partner with manufacturing, supply chain and development to ensure compliant product quality and robust processes.

The role emphasizes Design Control, MDR/IVDR readiness, data analysis and internal/external audits, with a focus on continuous improvement and Lean initiatives across the QMS.