Sr. Process Engineer - Device Assembly & Packaging
from CAPA’s. Lead or participate in IQ/OQ/PQ activities (including commissioning activities of new equipment or areas...
from CAPA’s. Lead or participate in IQ/OQ/PQ activities (including commissioning activities of new equipment or areas...
/OQ/PQ/ and cycle development protocols including development of final reports Represent/defend validation strategies...
of the project activities (from requirements phase to PQ). Your role will involve collaborating closely with the Engineering...
with suppliers. Supports IQ/OQ/PQ validation efforts within Edwards and at suppliers. Ensure proper documentation is completed...
and Standard Operating Procedures, and related documentations;and overseeing the functional and validation testing, IQ/OQ/PQ...
-certified quality systems and GD&T standards. - Experience in validations (e.g., TMV, GRR, OQ/PQ). - Ownership of data metrics...
., TMV, GRR, OQ/PQ). Proficient in Microsoft Office Suite Ownership of data metrics and monitoring for accuracy...
Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) on manufacturing equipment...
for instrument calibration, commissioning, and IQ/OQ/PQ Qualifications Hold minimum of a Bachelor's Degree in Engineering...
developing and executing IQ/OQ/PQ Experience in DOE development and execution, capability analysis, data collection...