[O958] - Regulatory Compliance Auditor

[O958] - Regulatory Compliance Auditor

**JABIL HEALTHCARE**

**Solicita**:
**Regulatory Compliance Auditor**

**Descripción y Requisitos**

**Overall objective of the position**
The Compliance Engineer, under the supervision of Compliance Manager, will support the internal audit program to help the site sustain a state of readiness to applicable regulatory and company requirements.
**Authority**
Monitor and ensure compliance of internal audit program, as well as provide support to the site to ensure continuous maintenance and effectiveness of the Quality System.
**Responsibilities**
Under supervision and in accordance with all applicable federal, state and local laws/regulations and Jabil procedures and guidelines this position is responsible for supporting:




External inspection readiness and associated activities.
Support site audit readiness activities to ensure inspection readiness at all time.
External audits: e.g., Notified Body, Ministry of Health country inspections, FDA, Customer Audits, Jabil Global 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 sites 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 execution 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 improvements, which result from audits,



Gemba walks and other system indicators
Ensure quality system is periodically evaluated and audited and appropriate preventive/ corrective action is taken to meet the business and regulatory requirements.
Support creation of reports and communicate performance against metrics to key stakeholders.
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
Perform other duties assigned as needed
Performs all duties in alignment with the Jabil Corporate Code of Ethics, Corporate and Global policies, Employment Labor Laws, Health Regulatory Agency Regulations, and Safety Requirements

**Functional objectives**
Provide support in meeting corporate, plant, departmental and individual objectives.
**Activities and periodicity**
Internal Audit Program development and execution Monthly
Support site audit readiness activities to ensure inspection readiness at all time Monthly
Support external audits (Notified Body,



Ministry of Health country inspections, FDA, Customer Audits, Jabil Global Audits for site) Monthly
Support implementation of new external standards/regulations for the site Monthly
Provide input into Site Management Reviews (e.g., internal audits) Eventually
Provide compliance education and training (QSR, ISO, GMPs) to the organization Eventually
Support mock inspections Eventually

COMPETENCES
**Hard skills**
Knowledge of 21CFR 820, ISO 13485, ANVISA and Ministerial Ordinance No.
169
Knowledge of CAPA System
Knowledge of root cause analysis
**Soft skills**
Builds trusting relationships
Develops self and others
Resilient
Decisive
Agility
High attention to detail
Ability to make complex issues simple
Excellent communication skills (written & oral)
Team player
Excellent time management




Focus on achievement and delivery of results
Active listener

**JOB PROFILE**
**Academic level (minimum required)**
- Bachelor's degree
**Proven experience**:

- Two to three years of experience in similar positions.
**Domain of operations**
ISO 13485 Lead Auditor certification is recommended
Lead Auditor qualification is recommended
Experience in performing audits is recommended
Experience in interaction with Health Authorities and Notified Bodies is recommended
**English: Business fluent**
- salario 30k

Puesto: Administracion**Información Adicional**
- Tipo de contrato: Permanente- Salario: Negociable
- Pais: MEXICO
- Estado o Region: Chihuahua
- Ciudad: Ciudad Juarez

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