Quality Engineer - Añasco
2 weeks ago
Job summary
Support the implementation of effective quality engineering processes for new products processes and technology Provides support to the validation and certification of process test methods equipment software utilities and facilities as required Generates test protocols monitors testing issues qualification test reports and approves qualifications plans/reports Supports activities documents records requiring Quality Engineering review approval Alerts the organization to issues in time to resolve potential adverse effects on the customer company image or reputation of the business Works with multi-functional teams to establish project plans ensure uninterrupted support to new projects balanced with manufacturing operations Develops standard operating procedures specifications provides technical transfer validation support Utilizes appropriate risk management tools prevent unanticipated failure modes improve capability of processes
Qualifications
- Bachelor's degree in Engineering minimum three years exposure Quality activities within Pharmaceutical Medical Device Industry Excellent verbal/ written communication skills English Spanish Experience Validation Life Cycle Change Control Documentation GMP GDP regulations Shift Administrative according business needs
Responsibilities
,-
- Support i the i implementation/ofofuitequalityengineeringprocessesfornewproductsprocessesandtechnology.
- /SProvideevidence./sstohevalidationandeertificationofprocesstestmethodsequipmentsoftwareutilitiesandfacilitiesasarerequired.
- GeneratesTestProtocolsmonitortestingissuesqualificationtestreportsandapprovesqualificationsplans/reports.
- SUPPORTSACTIVITIESDOCUMENTSRECORDSREQUIRINGQUALITYENGINEERINGREVIEWSUPPORTALERTSTHEORGANIZATIONTOISSUESINTIMETORESOVEPOTENTIALADVERSEAFFECTSONTHECUSTOMERCOMPANYIMAGEORREPUDATIONOFBESINESSWORKSWITHMULTIFUNCTIONALTEAMSTOESTABLISHPROJECTPLANSANDENSUREUNINTERRUPTEDATABASEDWITHMANUFACTURINGOPERATIONSDEVELOPSTANDARDOPERATINGPROCEDURESSPECIFICATIONSANDPROVIDESTECHNICALTRANSFERVALIDATION SUPPORTUTILIZESAPPROPRIATERISKMANAGEMENT TOOLSPREVENTUNANTICIPATEDFAILUREMODESANDEXPERIMENTCAPABILITY OFPROCESS
Job description
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