Quality Manager - Medical Device/ ISO 13485
actions Validation activities (IQ/OQ/PQ) Complaint investigations Document control and change management Physical...
actions Validation activities (IQ/OQ/PQ) Complaint investigations Document control and change management Physical...
testing, and providing feedback to support production implementation Support and assist in IQ, OQ, and PQ qualifications...
(QMSR), ISO 13485, supplier quality systems, process validation methodologies (IQ/OQ/PQ), and regulated manufacturing... (IQ/OQ/PQ), or supplier quality improvement initiatives preferred. About Hamilton Established, stable, and reliable...
and execution are robust, including FAT, IQ, OQ, PQ, computer systems validation where applicable, design reviews, and readiness..., validation lifecycle, FAT, IQ, OQ, PQ, process characterization, and technical investigations is preferred. Experience...
(FAT, IQ, OQ and PQ) Must be fully bilingual: Spanish & English Proficiency with Microsoft Office: Word, Excel...
/OQ/PQ). Support capital projects or equipment upgrades involving vision system deployment or optimization. Provide day...
), and general assembly Develop, document, and qualify (IQ/OQ/PQ/PPQ) new manufacturing and test processes using statistical tools...
, Maximo, and SharePoint. Knowledge of pharmaceutical regulations and industry practices such as GMPs, GLPs, AAALAC, IQ/OQ/PQ...
. Performance of Installation Qualification (IQ), Operation Qualification (OQ), and Product Qualification (PQ). Observe Good...
on capital projects, managing associated resources, financial decisions, and validations (e.g., FAT, SAT, IQ, OQ, PQ). Coordinate...