• Extensive knowledge of quality engineering, and or quality systems for medical devices
• In-depth knowledge of the concepts of; design control, engineering change control, statistical techniques, verification and validation methods/protocols, risk management, design history files (DHF), device history and master records (DHR/DMR), CAPA, 510(k), complaint handling etc.
• Well-versed in the methodologies of verification and validation for medical devices
• Sound knowledge of FDA Quality System Regulations; 21 CFR Part 210, 211, especially 21 CFR Part 820 and 21 CFR 820.198 etc. Knowledge of the European Medical Device (MDR) regulations a plus
• Sound knowledge of ISO13485 for medical devices
• Quality engineering concepts such as; statistical analysis, measurement and calibration systems, quality testing, sampling and inspection, process control, SOPs, engineering change notices etc.
• Audit experience a plus
• Knowledge of basic computer applications, Microsoft suite of tools (Word, Excel, Power Point etc.), Minitab for statistical analysis, SAP and Trackwise systems a plus
  Can communicate effectively
• Must be able to work under minimal supervision on somewhat ambiguous tasks 

• An opportunity to be a part of a great culture, an awesome team, a challenging work environment, and some fun along the way!
• Apply today to learn more and be part of our Growth story.

Department: Scout
This is a full time position