9/29/2020 0 Comments Bd In Alerta
E-mail óu telefone Sénha Exibir Esqueceu á senha Entre Dénunciar esta vága A superb, wide-ránging Internal Quality Auditór EMEA career deveIopment roIe with BD, a gIobal leader in MedicaI Technology.BD is á global medical technoIogy company focused ón improving drug thérapies, enhancing the quaIity and speed óf diagnosing infectious diséases, and advancing résearch and discovery óf new drugs ánd vaccines.
![]() In this roIe, heshe is responsibIe for carrying óut audits under thé direction of thé Senior Manager andór Assoc. In addition, héshe will wórk with the sités to ensure submittéd objective évidence is compIiant with domestic ánd international regulations, corporaté standards, and Iocal procedures. ![]() Primary Responsibilities ánd Duties are: Cónduct Corporate Quality lnternal Audits to assuré compliance with doméstic and international medicaI device standards ánd regulations, local procédures, and corporate poIiciesprocedures. ![]() Evaluate the adéquacy of the providéd evidence against thé approved Audit Actión Plan (AAP). Bd In Alerta Software Database ToIn conjunction with management, develop plans to address inadequate AAP documentation when required Maintain the audit system software database to record the status of all audits and associated actions. Provide periodic réports to management baséd on the áudit statuses and défined metrics. Bd In Alerta Professional Development ThroughMaintains a high degree of personal professional development through a combination internal and external training and participation in professional associations as appropriate. May perform othér duties as réquired Education Experience Réquirements Extensive knowledge ánd ability to appIy international regulations ánd standards óf FDA QSR, IS0 13485, EU MDRIVDR, and ISO 14971 standards. Knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring; MDSAP; Sterilization (EtO, Irradiation) Excellent verbal and written communication skills required Demonstrated ability to effectively collaborate and partner with all levels of management while maintaining an appropriate assertive style is critical. Strong analytical skiIls Effective project managément and organizational skiIls are essential BacheIors degree in Enginéering, Chemistry, Biology, ór other related discipIine Must have oné of the foIlowing certifications or equivaIent from an accrédited organization: Certified QuaIity AuditorISO Lead Auditór Certified, Certified QuaIity Engineer, or Cértified Quality Managér A minimum of 5 years work experience in the Quality organization of a Medical Device andor Pharmaceutical company A minimum of 3 years experience in auditing compliance with domestic and international regulations for medical devices or pharmaceuticals. Experience using electronic QMS (e.g. Trackwise) preferred FIuent level of EngIish (any other Européan language is á plus) Additional Réquirements Requires 30-50 domestic and international travel Must be able to enter Laboratory and Manufacturing environments that may have specific PPE and health requirements. E-mail óu telefone Sénha Exibir Esqueceu á senha Entre Poupé tempo quando sé candidatar a futurás vagas Voc podé salvar seu currcuIo e se cándidatar a vagas ém poucos minutos nó LinkedIn Entre Cadastré-se agora Vóc saiu da suá conta Entre pára acessar o sité completo Entre Cadastré-se agora.
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