Quality Assurance Engineer
Core
Supports manufacturing and operational quality activities, focusing on investigations, data analysis, and process improvement to ensure products meet regulatory requirements.
Role type
Site Quality Assurance Engineer I
Builds
Medical devices and software solutions for cardiopulmonary and respiratory care
Domain
Medical devices / Manufacturing Quality
Required skills
Root cause investigation, data analysis, process validation, nonconformance management, supplier quality support, regulatory compliance (FDA/ISO), documentation management
Preferred skills
Supplier quality investigations, corrective action activities, quality system tools, data analysis tools
Technologies
Quality system tools, data analysis tools
Responsibilities
Support investigations related to manufacturing and operational quality issues; Analyze manufacturing quality data to identify trends and improvement opportunities; Assist in nonconforming material investigations and Material Review Board activities; Support process validation and equipment qualification activities; Participate in manufacturing process improvement initiatives; Assist with supplier quality investigations and corrective action activities; Support internal audits and regulatory compliance activities
Seniority
Junior, hands-on IC