Position Overview

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
  • • 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 • Degree in related field or equivalent • Minimum of 3-5 years of related experience • Good communication skills