Responsible for personnel, 6S, and safety management within the scope of responsibility, ensuring a good production order and a safe working environment.
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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Ensure and monitor that the manufacturing lines have available appropriate manufacturing documentation to assembly products such as visual Aids, Physical Visual aids y manufacturing documentation.
Ensure manufacturing lines have printed and posted in each process workbench visual aids and physical visual aids as required for easily access of the document in a manner that the associate and leads can have product acceptance criteria as reference
Ensure adherence to procedures and to good manufacturing practices.
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