. Perform and analyze IQ, OQ, PQ qualifications and other validation activities. Collaborate with cross-functional teams... of experience in process validation (medical device experience required;not pharma). Hands-on experience with IQ, OQ, PQ and FMEAs...
experience. Orthopaedic experience preferred. Expertise in FMEAs and IQ, OQ, PQ validation. Strong understanding of regulatory...
, PQ) protocols, engineering studies and final reports that comply with corporate and regulatory requirements. Coordinate...
Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation (PV). Collaborate...
quality. Ensure equipment qualification, process validation (IQ/OQ/PQ) and process control plans are implemented...
and preventive actions (CAPA) and writing validation reports (IQ/OQ/PQ). Solid knowledge of GD&T, PFMEA and Control Plans...
projects. Drive process improvements, change control, and validation activities (TMVs, IQ/OQ/PQ). Direct preventive...
activities for construction projects. Develop Cx protocols, URSs, SOPs, IQ/OQ activities, and PQ for mechanical and utility...
protocols (IQ/OQ/PQ). Project & Financial Skills: Highly skilled utilizing Microsoft Project for schedule/project plan...
–design-freeze activities such as tooling, fixtures, process characterization, and validation (IQ/OQ/PQ). This engineer serves..., validated production processes. Prepare process development plans, documentation, and validation protocols (IQ/OQ/PQ). Drive...