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Quality Engineer Role for a Medical Devices Company. Primary responsibilities will be Test Method Validations, Analysis with Minitab Software, IQ/OQ/PQ, Non-Product Software Validation, PFMEA, DFMEA, in accordance with ISO 14971, ISO 13485.
Job Responsibility:
Test Method Validations
Analysis with Minitab Software
IQ/OQ/PQ
Non-Product Software Validation
PFMEA
DFMEA, in accordance with ISO 14971, ISO 13485
Requirements:
Bachelors Degree
Class II Medical Device experience performing Design Transfer activities per FDA CFR 820
Experience with Test Method Validations
Experience with Analysis with Minitab Software
Experience with IQ/OQ/PQ
Experience with Non-Product Software Validation
Experience with PFMEA
Experience with DFMEA, in accordance with ISO 14971, ISO 13485