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Quality Engineer Role. Looking for Class II Medical Device experience performing Design Transfer activities per FDA CFR 820. 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:
Perform Design Transfer activities per FDA CFR 820
Perform Test Method Validations
Perform Analysis with Minitab Software
Perform IQ/OQ/PQ
Perform Non-Product Software Validation
Perform PFMEA
Perform DFMEA
Work in accordance with ISO 14971
Work in accordance with ISO 13485
Requirements:
Class II Medical Device experience performing Design Transfer activities per FDA CFR 820