Leads and participates in problem solving activities related to manufacture and inspection and test, including NCR and supplier related issues
Communicates significant issues or developments during quality inspection activities and through analysis provides plans and recommendations to the team and management for resolution
Leads and/or participates in IQ/OQ and PQ activities, test sample size selection, test method validations, Gage R&R studies and risk management activities to assure conformance to product quality standards and applicable regulations
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Performs and documents initial reportability decisions on complaints in accordance with regulations (US FDA) and international regulations (MEDDEV Vigilance, Health Canada, and others as applicable) and company procedures; Elevate complaints that require additional review for regulatory reporting.
Verify that the correct number of complaints have been opened to address all of the issues identified in the complaint description. If required, generate additional complaint records to document all of the issues listed in the complaint description.
Ensure that all complaints requiring customer responses are properly addressed, as assigned; drafts and documents the response in the complaint file.
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