Manufacturing Validation Engineer

Overview

On Site
40 - 45
Contract - W2
Contract - 12 Month(s)
No Travel Required
Unable to Provide Sponsorship

Skills

Documentation
GD&T
IQ
ISO 9000
Master Control
JMP
ISO 13485
GMP
Minitab
Medical Devices

Job Details

Job Description:

    1. Manufacturing process validation (IQ/OQ/PQ), medical device manufacturing, and new product introduction (NPI).
    1. GD&T, design & development, equipment qualification, calibration, metrology, and Gauge R&R.
    1. Statistical analysis using Minitab/JMP (Cp, Cpk, process capability studies).
    1. Knowledge of ISO 13485, GMP, 21 CFR Part 820, ISO 14971, and eQMS tools (MasterControl, ETQ).
    1. Experience with CNC machines, CAM software, and manufacturing process documentation.
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