Manufacturing Process Validations

• Experience in supporting medical device manufacturing.
• Specific experience with process characterization, equipment IQ/OQ, process OQ, and PQ
• Validation Experience, especially cleaning
• Processes experience, molding, cleaning, packaging
• Specific experience with Test method Validation and Gage R&R
• Experience with root cause analysis and problem-solving for both technical and process issues
• Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003
• Ability to lead and prioritize multiple medium-complexity project assignments and complete work in a timely manner.
• Good problem-solving skills through the use of quality and statistical tools, Six Sigma
• Ability to read and understand engineering drawings.
• Knowledge of basic quality tools, risk analysis (PFMEA), statistics (SPC), Critical-to Quality (CTQ) Analysis
• Knowledge of Quality System requirements, ISO and FDA requirements

Last updated on Sep 21, 2023