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Revise and approve all documentation related to the areas of responsibilities such as In Process Checker Charts, Product Retention Records, Control Charts, Mold Approvals, Batch Records related and others
Responsible for routine manufacturing audits of machine parameter and/or set-ups for compliance as well as the product manufactured
Perform routine audits of sampling techniques testing skills and all documentation performed by the TIQ's
Responsible for an immediate notification and awareness to Quality Management of potential Quality situations
Assist and coordinate protocols
Provide training as required on Good Documentation Practices, SPC, Total Integrated Quality and others
Provide support regarding mold approval and mold start up evaluations (if applied)
Gather, analyze, audit and interpret data using SPC methods so as to be able to predict trends and recommend process improvements that would impact favorably on product quality, scrap reduction, DPM reduction, Complaints reduction, price of non-conformance reduction and others
Insure that all machinery, equipment, tools or any other measuring, monitoring material complies with Corporate, GMP and other regulatory requirements
On a monthly basis publish Quality Indicators including DPM’s, Pareto Analysis on responsibility areas
Submit improvements and/or modifications to specifications and Standard Operating Procedures
Maintain good timely communication and awareness on DPM and complaints trends with the internal and external customers/suppliers
Assist in the development / certification of the TIQ’s
Perform special projects related to responsibility areas
Manually document (ex: checker chart) and/or electronically (ex: POMs) the required information to comply applicable procedures and specifications
Observes all company and regulatory EHS requirements
Observe data privacy policies at all time
Provide support on Software application audits execution
Assist on the generation and investigation of non-conformities
Requirements
Bachelor Degree Science
At least two years of experience dealing with related job on Medical Device Industry
Knowledge in Data Entry – Microsoft Office Software