Position Overview

The Quality Engineer II supports the development and manufacture of medical devices.
  • Will work with Manufacturing and R&D to resolve product quality issues.
  • Supports manufacturing process changes, product design improvements and the implementation of new products.
  • Works with manufacturing engineers to review process changes and resolve product quality issues
  • Works with suppliers to maintain high quality levels of incoming production materials
  • Conducts quality audits of suppliers
  • Work with R&D engineers to support implementation of new products by reviewing quality and testing plans
  • Works with R&D and manufacturing engineers to develop the DFMEA and PFMEA
  • Works with R&D and manufacturing engineers to develop test protocols and reports (design verification, design validation, process qualification and process validation)
  • As assigned, maintains various Quality Systems such as CAPA, Non-Conformance (NCR), supplier quality, equipment calibration, internal auditing and quality metrics data analysis
    • Degree in Chemistry or Material Science
    • Minimum of 3-5 years of related experience
    • Knowledge of medical product manufacturing
    • Ability to understand the technology related to MicroVention’s products
    • Knowledge of medical product quality assurance (including the requirements for test protocols and statistical techniques)
    • Computer skills including Statistical Software (MiniTab, Statgraphic, Design of Experiment DOE), MS Word & Excel
    • Good communication skills