Overview
Quality Assurance Specialist Jobs in Madison, WI at Indotronix Avani Group
Title: Quality Assurance Specialist
Company: Indotronix Avani Group
Location: Madison, WI
Summary
This position will have a wide range of tasks which may include product complaint investigations, root cause analysis (RCA), manufacturing quality process development, maintenance, trending and reporting, deviation investigation, CAPA management, change management, internal/external auditing, supplier quality management, and direct involvement and collaboration with the Operations, Technical Operations, Engineering, and Materials Management groups to drive quality culture.
Principal Responsibilities:
Perform trending and analysis of customer complaint data
Drive investigations and manage deviations and NCMRs from initiation to disposition
Perform and lead RCA’s through cross-functional team involvement
Support the development and maintenance of manufacturing quality control processes for new and existing production areas
Support supplier quality management for desk audit and quality agreement creation, execution, and review via direct customer contact
Maintain process Failure Mode and Effects Analysis for new and existing production areas
Manage CAPA creation and ensure adequate effectiveness
Improve existing procedures to align with cGMP and regulatory requirements
Interpret and properly apply all applicable regulatory requirements
Improve quality culture through site initiatives
Review and approval of procedures, protocols, reports, etc… as required.
Perform internal and external audits of systems and suppliers
Filing and management of documentation when required
Supporting other Quality System Functions
Minimum Requirements:
Bachelor’s, or higher, degree in engineering or applicable science/technology program
3+ years of experience in a cGMP Quality Assurance/Compliant environment (medical devices preferred)
Technical writing
Statistical analysis – Minitab or other software equivalent, preferred.
