Job Description: 6-8 years of Quality engineering experience. Quality Engineering experience in Medical Devices (at least in Class I & II) at least 3 years. Full Quality System Knowledge. Extensive Gage R&R experience. Process FMEA. Process Control Plan Measurement System Analysis Studies (Gauge R&R). Process Capability Analysis (Cpk). Process Qualification (e.g. IQ, OQ, PQ). First Article Inspection (FAI). First Production Inspection (FPI). Critical to Quality (CTQ).
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