Quality Engineer

Job description

DEKA R&D has an immediate opening for a Quality Engineer to work in the Quality Department in a dynamic Medical Device Research and Development environment. The position reports to the Quality Manager. We are seeking a Quality Engineer to provide Quality guidance in a dynamic, fast-paced medical device research, development, and manufacturing and distribution environment. How you will make an impact: - Work cooperatively with cross functional design team members and project management to determine the best approach for on-going compliance with applicable SOPs and regulations, such as 21 CFR 820 and ISO 13485 - Participate in and lead Risk Management activities in accordance with ISO 14971 - The development, implementation, and approval of Hazard Analyses, FMEAs, and other Risk Analysis documentation. - Lead investigations including root cause identification, corrective actions, and verification of effectiveness, through use of data analysis, inductive and deductive reasoning, and problem solving skills. - Coordinate the efforts of individuals and teams performing investigations. - Use experience within manufacturing and monitoring of medical devices, to provide guidance in Root Cau...