investigation tools Understanding of process validation (IQ/OQ/PQ) Understanding of Lean Manufacturing and Six Sigma...
to support Process Qualification efforts (IQ, OQ, PQ etc.) for all classes of medical devices. Internal contacts...
for all production instrumentation: IQ/OQ/PQ, owning equipment protocols/SOPs, coordinating PMs/calibration/requalification, maintaining...
or equivalent experience. 4+ years of experience in a regulated manufacturing environment. Knowledge of APQP, PPAP, IQ/OQ/PQ...
. Develop and execute commissioning, qualification, and validation protocols (IQ/OQ/PQ) for cleanroom environments and large...
CSV IQ/OQ/PQ scripting protocols and reports. Collaborate and build relationships with manufacturing groups to ensure...
), and Performance Qualification (PQ) protocols Support non-conformance investigations by inspecting components, reviewing documentation... and experience preparing or reviewing documentation such as SOPs, MIs, IQ/OQ/PQ protocols, or NCIRs (Non-Conformance Investigation...
of Quality tools/methodologies including process validation (IQ, OQ, PQ). Understanding of statistical analysis and sampling...
through the installation of a new process or equipment Complete validation requirements for any new system (IQ, OQ, and PQ...
Administration or another related field Certified Quality Auditor Knowledge of validation processes (IQ, OQ, PQ, PPAP) Knowledge...