Saltar al contenido principal
Volver a la búsqueda

Compliance Engineer II

Req ID: J2293568

  • Ubicación
    Torres, Chihuahua, Mexico
  • Categoría Riesgos y Garantias
  • Publicado martes, 2 de noviembre de 2021
  • Tipo Tiempo completo
  • Tipo de Empleo Empleado Permanente

Descripción del Trabajo

The Compliance Engineer, under the supervision of Compliance Manager, will lead and maintain the internal audit program to help the site sustain a state of readiness to applicable regulatory requirements. 

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • External inspection readiness and associated activities.  Support site audit readiness activities to ensure inspection readiness at all time.

  • Support external audits: e.g. Notified Body, Ministry of Health country inspections, FDA, Jabil Corporate Audits for site. 

  • Participate in audit preparation activities (auditor logistics, front room/back room arrangements, identifying/preparing SME’s, etc.).

  • As required, assess the risk and applicability of audit observations from other Jabil facilities to determine impact to the site.

  • Support mock inspections as part of External Inspection Readiness activities.

  • Provide timely information to support the inspection process.

  • Internal Audit Program and Management Execution

  • Execute against established internal audit procedures.

  • Ensure adequate corrective actions for internal audits, including investigations and corrective action plans, drive on-time completion of observation action plans, perform follow-up with observation owners, and perform effectiveness monitoring and closure.

  • Drive compliance and improvement in internal audit metrics.

  • Ensure quality system is periodically evaluated and audited and appropriate preventive/ corrective action is taken to meet the business and regulatory requirements.

  • Enterprise / Sector Support

  • Connect and collaborate with other regions compliance teams. 

  • Create reports and communicate performance against metrics to key stakeholders.

  • Highlight/communicate adverse trends in metrics, and take risk based action to remediate. 

  • Escalate items in accordance with established procedures.

  • Support implementation of new external standards/regulations for the site.

  • Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings.

  • Provide input into Site Management Reviews (e.g., internal audits.) to allow meaningful review.

  • Establish strong connection and collaboration with business partners at the site, (e.g. Quality Operations, Training, and Manufacturing).

  • Provide compliance education and training (QSR, ISO, GMPs) to the organization in support of overall educational strategies.

  • Support and promote the safety and environmental objectives of the facility. Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001).

  • Responsible for communicating business related issues or opportunities to next management level

  • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

  • Performs other duties assigned as needed


JOB QUALIFICATIONS
KNOWLEDGE REQUIREMENTS

  • Thorough knowledge of the Text document systems on Document Management System.

  • Good written and oral communication skills as well as report writing, presentation and training skills both in English and Spanish.

  • Good interpersonal skills; customer service oriented.

  • Knowledge of Good Manufacturing Practices (GMPs) and Quality System Regulations (QSRs) preferred. 

  • Current Certified Quality Audit (CQA), Certified Biomedical Auditor (CBA) and/or Lead Auditor certification preferred. 

  • Experience in leading and managing projects and milestones preferred. 


EDUCATION & EXPERIENCE REQUIREMENTS

  • Requires 2-4 years related experience

  • University/Bachelors Degree

Image 17 (1)

¿No estás listo para aplicar? ¡Únase a la red profesional de Jabil!

Más información sobre las próximas oportunidades profesionales y eventos Jabil

Únete ahora