Job Summary
Incumbent will be responsible for insuring compliance with the Quality System Regulation regarding quality and manufacturing processes and methods. In order to perform effectively the incumbent must be knowledgeable of all processes, product, specifications and quality functions.
Duties/Responsibilities:
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. Maintains, revise and audits control chart and compute control chart limits as required.
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. (if apply)
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. This information includes but is not limited tp process parameters, lots, amount of production, and others.
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
Education/Experience
Bachelor Degree Science.
At least two years of experience dealing with related job on Medical Device Industry.
Qualifications
Knowledge in Data Entry – Microsoft Office Software. Basic computer knowledge is required Experience in measurements instrumentation. Good interpersonal skills. Willing to travel occasionally.
Tipo de puesto: Tiempo completo
