Quality Engineer

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 ...