NEW OPEN POSITION : QA Eng. II
Qualifications and Experience
oBachelor's degree in Engineering discipline or equivalent
oMinimum of 3 - 4 years’ related experience and/or training; preferably in the medical device industry
ofamiliarity with regulatory requirements (FDA 21CFR820, ISO 13485:2016)
oAdvanced English writing, reading, speaking and listening skills
oGood verbal and written communication skills, with demonstrated ability to generate technical reports, and ability to make presentations to middle and upper management
oKnowledge of Cleanroom environmental requirements and testing methodologies for those requirements
oExperience in Validation (TMVs, CQs, IQs)
Job Duties
oMonitors applicable environmental metrics and acts upon trends
oApplies statistical methods to environmental monitoring evaluation, problem-solving and improvement
oEnsure Product Release completion and COC/COA documentation
oDevelops new approaches to solve known problems as part of the team
oAssist in the compliance and maintenance of standards (e.g., FDA, ISO 13485), Quality policies and procedures
oComplete assigned tasks in a timely manner
oRun Equipment Validation for NPD
Estaremos recibiendo CV hasta el viernes 29 de Octubre 2021 .
Enviar al correo: gmb-dom-reclutamiento@carefusion.com/ dennis.veloz@bd.com
Qualifications and Experience
oBachelor's degree in Engineering discipline or equivalent
oMinimum of 3 - 4 years’ related experience and/or training; preferably in the medical device industry
ofamiliarity with regulatory requirements (FDA 21CFR820, ISO 13485:2016)
oAdvanced English writing, reading, speaking and listening skills
oGood verbal and written communication skills, with demonstrated ability to generate technical reports, and ability to make presentations to middle and upper management
oKnowledge of Cleanroom environmental requirements and testing methodologies for those requirements
oExperience in Validation (TMVs, CQs, IQs)
Job Duties
oMonitors applicable environmental metrics and acts upon trends
oApplies statistical methods to environmental monitoring evaluation, problem-solving and improvement
oEnsure Product Release completion and COC/COA documentation
oDevelops new approaches to solve known problems as part of the team
oAssist in the compliance and maintenance of standards (e.g., FDA, ISO 13485), Quality policies and procedures
oComplete assigned tasks in a timely manner
oRun Equipment Validation for NPD
Estaremos recibiendo CV hasta el viernes 29 de Octubre 2021 .
Enviar al correo: gmb-dom-reclutamiento@carefusion.com/ dennis.veloz@bd.com
No hay comentarios.:
Publicar un comentario
Déjanos tú comentario