Director Medical Device Manufacturing Operations
validation (IQ/OQ/PQ), equipment qualification, and manufacturing documentation systems *Please see the full...
validation (IQ/OQ/PQ), equipment qualification, and manufacturing documentation systems *Please see the full...
validation master plan, developing and executing protocols (PQ/PPQ) to ensure cGMP compliance and equipment readiness. Lead... protocols (IQ/OQ/PQ). Preferred Qualifications Proficiency in statistical analysis software (e.g., Minitab) and SAP Prior...
, and executes IQ, OQ, and PQ protocols and reports for equipment/systems. Conducts risk assessments and develops qualification...
, including: Supplier pFMEA IQ/OQ/PQ and process validations First Article Inspections and inspection reports Gage R&R...
, Validation & Analytical Methods Design and execute validation protocols (IQ/OQ/PQ) for equipment, processes, software...
of IQ, OQ, PQ where appropriate. Support development, ordering and control of process related tooling, equipment...
with process validation activities, including IQ/OQ/PQ and DOE preferred. Proficiency with Microsoft Office and statistical...
and author pFMEAs, validation protocols (IQ/OQ/PQ), process specs, and change orders Collaborate cross-functionally with R...
and execute supplier qualification and validation activities, including: Supplier pFMEA IQ/OQ/PQ and process validations First...
, SAT, commissioning, and IQ/OQ/PQ protocols and reports Perform and maintain risk management activities for new...