Descripción y detalle de las actividades
Develops, plans, and coordinates activities to achieve and maintain external certifications including scheduling, planning, and carrying out internal audits and developing and providing training to internal auditors.
- Prepares the annual internal audit schedule; performs audits and leads audit teams, and evaluates compliance with scheduled audits.
- Adjusts audit schedules and conducts special audits as necessary.
- Ensures effective and timely closure of audit findings; monitors the status of certifications and re-certifications; ensures appropriate training and communications exist on issues impacting the Quality and Environmental Systems team.
- Creates and maintains internal audit reports; effectively communicates audit results; ensures follow-up and closure of audit findings.
Monitors audit activities, corrective actions, and conflict resolution found during internal audits.
- Coordinates with Quality Systems Manager and supervisors to identify and develop departmental training needs.
Continually monitors audits for timeliness, completion, and follow through.
Maintains audit metrics.
- Provides training and instruction to internal auditors and assigns internal auditors to audit teams.
- Performs other related duties as assigned.
- Internal Audit Program Execution against established internal audit procedures.
- Ensure quality system is periodically evaluated and audited and appropriate preventive/ corrective action is taken to meet the business and regulatory requirements.
- Provide compliance education and training (QSR, ISO, GMPs) to the organization in support of overall educational strategies.
Experiência y requisitos
- Bachelor's degree required.
- 4+ years of experience in similar positions.
- Knowledge of the U.S. and international medical device quality system regulations, standards, and best practices (21 CFR 820, ISO 13485).
- Knowledge of CAPA System.
- Knowledge of root cause analysis.
Organización
Jabil Healthcare
Giro
Maquiladora (Export.)
Actividad principal
Manufactura de productos médicos.
Número de empleados
3500
/jabil_careers//solutions/by-industry/healthcare.html**Área** Calidad
**Contrato** Permanente
**Turno** Diurno
**Jornada** Tiempo Completo
**Estudios** Carrera Profesional
**Inglés **Hablado: 90%, Escrito: 90%
**Sexo** Indistinto