Quality Engineer- Anesthesia
$79,000–$119,000 year
On-siteChicago, Illinois, United States
Job Summary
Manage the development and implementation of methods and procedures for process control, validation, and inspection to ensure products are ideal and functional. Design experiments to understand sources of variation, apply statistical process control (SPC) methods for data analysis, and conduct experimental product testing to minimize defects. Generate and analyze reports on defective products to determine trends and lead corrective actions, while collaborating with supplier representatives on quality problems and implementing CAPA. Lead investigations of non-conformances and out-of-specification results, and provide Quality expertise in design control, risk management, and CE technical files. Coordinate product testing with internal and external laboratories as required. Position requires up to 15% travel.
Required Qualifications
- 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, depending on oneself to complete objectives, and determining when escalation of issues is necessary
- Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects
- Experience problem solving, overcoming obstacles, and reaching a positive and successful solution through mathematical or systematic operations
- Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook)
- Intermediate Skill Level in Microsoft Excel (for example: conditional formatting, tables, formulas, charting)
- Working knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485)
- Position requires up to 15% travel
Desired Qualifications
- 2+ years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role
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