Descripción y detalle de las actividades
- responsible for implementing quality and regulatory audits and providing training and guidance for quality auditors
- monitors the timely completion of corrective action plans and coordinates the reporting of compliance metrics to business unit/region and manufacturing facilities.
- uses training, experience, and the information collected during audits to assist with problem solving and continuous improvement projects as assigned
- coordinate and conduct routine and focused quality system audits as assigned to assess compliance with domestic and international regulations and standards, and corporate, segment, unit, and local procedures and policies
- establishes audit teams through the use of qualified bd quality auditors and contracted auditors.
- conducts quality audits to assure compliance with domestic and international medical device standards and regulations, local procedures, and corporate policies/procedures.
- follows up with the auditee as required to compile information relating to the audits.
- evaluates the adequacy of the provided evidence against the approved audit action plan in conjunction with management, develop plans to address inadequate aap documentation when required.
- maintains the audit system software database to record the status of all audits and associated actions.
- provides periodic reports to management based on the audit statuses and defined metrics.
- maintains a high degree of personal professional development through a combination internal and external training and participation in professional associations as appropriate.
- this individual will be interacting with individuals at various levels of the organization across multiple sites and at corporate during and when following up on audits.
this position regularly interfaces with bu and local leadership teams and compliance personnel to establish and implement schedules for corporate audits and gain acceptance/understanding of identified nonconformances without damaging the relationship with the site
experiência y requisitos
- b.s.
engineering, chemistry, biology or equivalent discipline, advanced degree is preferred.
- minimum 5 years of experience work experience in the *quality organization of a medical device and/or pharmaceutical company*.
experience with warning letters and other regulatory actions preferred.
- minimum of 2+ years' experience in with auditing compliance with domestic and international regulations for medical devices or pharmaceuticals.
- one of the below certifications or equivalent: (required) _
- *certified quality auditor/iso lead auditor certified*:
- * certified quality engineer*:
- * certified manager of quality / organizational excellence*:
- * exemplar global iso 13485 lead auditor certification or equivalent*(preferred)
- us valid visa (must)
- availability to travel 25-40% of the time
- advanced english level
beneficios
- fondo de ahorro
- gastos médicos mayores
- plan de pensiones
- seguro de vida
- aguinaldo superior a la ley
- programa de compra de acciones
- seguro dental
*número de vacantes* 1
*área* calidad
*contrato* permanente
*modalidad* híbrido
*turno* diurno
*jornada* tiempo completo
*estudios* carrera con título profesional
*inglés*hablado: avanzado, escrito: avanzado
*disponibilidad p. viajar* si