Quality Engineer

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