Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection.
Design experiments to understand sources of variation affecting products and processes.
Apply statistical process control (SPC) methods for analyzing data.
Design and perform experimental product testing and analysis to maintain quality levels and minimize defects.
Generate and analyze reports and defective products to determine trends and lead corrective actions.
Direct and collaborate with supplier representatives on quality problems.
Provide Quality expertise in Product Development, Design Control activities, Risk Management, and CE Technical Files.
Coordinate product testing with internal and external laboratories as required.
Perform quality reviews of design documentation for compliance with stated requirements.

Typically requires a Bachelor’s degree in Engineering, Science, Math or other related technical field.
2+ years of experience in the Quality or Engineering.
Experience developing ways of accomplishing goals with little or no supervision.
Experience using time management skills to prioritize, organize, and track details.
Experience problem solving, overcoming obstacles, and reaching a solution through mathematical or systematic operations.
Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).
Intermediate Skill Level in Microsoft Excel.
Working knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485).

Quality Engineer

Key skills