HireDiversity

Juarez, MX

Compliance System Administrator-00000A6P

Description

Compliance System Administrator

"Johnson & Johnson companies are equal opportunity employers"

The Global Job Posting policy promotes the commitment to the advancement and development of our employees. We invite you to read this posting and apply if you are interested in the position and meet the requirements.

Ethicon, Inc., a Johnson & Johnson company, is a trusted, world-wide leader in medical devices company who contributes to the advance surgery and improves lives every day. We are qualified as one of the top best place to work. Joining ETHICON is more than joining a great company, it means being a part of a legacy of innovation, development and philanthropy. For more information, visit www.ethicon.com

Searching the best talent for: Compliance System Administatror

Band: 24 Indirecta

Works under limited supervision of a facilitator, with responsibility to make compliance administrative decisions to meet departmental and internal/external customer needs

Demonstrate a thorough knowledge of facility and organizational policies and procedures

Interact with Quality Systems Departments from other facilities and provide support to Quality Systems corporate initiatives

Provides periodic reports, completes special assignments and assists facilitator, as assigned

Generate reports of each department progress and present to the appro­priate management along with recommendations for improvement as required.

Investigate, document, and implement corrective actions for non-conformances related to the documentation change process.

Originates procedure changes and performs implementation tasks

Maintains necessary supplies and equipment.

Develop enhancements, as needed, for the process and application tools.

Maintain the system and help to determine resource support for each department:

Support and promote the safety and industrial hygiene objectives of the plant

Document Controls (Key Procedure Maintenance, Paper Base Satellites, Maintenance and Audits, Visual Aids Management, etc..)

Operator Certification Program (support associates certification and related data monitoring, etc)

Audits Management System (create user profile, monitors non-conformances and action plans.)

Learning Management System (create courses, assign tasks, monitoring training, implementation activities create new accounts).

Develop and Maintain Records Management retention system for the Juarez Facility

Support Management Review activities

Quality Metrics monitoring and scorecard maintenance

Provides Litigation and Regulatory Information requests

Supports the maintenance of the Site Audit Readiness Program

Provides support Internal and External Audits, where applicable

Supports Site Internal Audit Program and perform Internal Audits as required.

Coordinate and assist in the development of training programs of all types and levels.

Provides training in QSR, ISO and other regulations, directives, standards and quality concepts.

Ensure compliance to the Quality Policy in all activities

Audit the process and the end users for compliance to the associated Company Proce­dures and training provided.

Ensure compliance with Plant policies, procedures, ISO13485-2003, 21CFR Part 820 and applicable standards and regulations

Translate new and existing documents (English-Spanish and Spanish-English) to support plant activities and new product transfers.

Ensure Ethicon Juarez documents are sent for archival according to Records Management policies and procedures, as applicable.

Ensure that the document scanning process adheres to the current procedures.

Reporting to: QA Compliance Engineer

Qualifications


High School Diploma as minimum

Bachelors Degree, preferred

Certified Translator, preferred

At least 3 years of experience in Quality Assurancebased manufacturing environment.

85% English skills

High level of computer skills

Knowledge in computer applications

Physical Demands: Normal Office Environment

Work Environment: Frequent Travel, Flexible to work on different shifts and sites, as required.

Contacts: Frequent contact with Ethicon facilities and Executive Management, as required.

Computer Literate; Bilingual

Thorough knowledge of the Text document systems and the Document Management System.

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

Accomplish objectives in a timely manner without day to day supervision.

Good interpersonal skills; customer service oriented.

Knowledge in Current Good Manufacturing Practices, ISO, QSR, and applicable Standard and Regulations and respective requirements.

At least 2 years of experience in Quality Assurancebased manufacturing environment.

Global Leadership Profile Competencies

Integrity and Credo-based Actions ~ lives Credo values; builds trust; tells the truth; initiates transparency into problems; demonstrates genuine caring for people.

Collaboration and Teaming ~ puts interests of enterprise above own; works well across functions and groups; builds teams effectively; inspires follower ship; instills a global mindset

Results and Performance Driven ~ assumes personal ownership and accountability for business results and solutions; willing to make tough calls; consistently delivers results that meet or exceed expectations; demonstrates a track record of people development; champions diversity; net exporter of successful talent.

Sense of Urgency ~ proactively senses and responds to problems and opportunities; works to reduce "cycle" time; takes action when needed

Other Considerations

Travel percentage 10%

Primary Location:
Ethicon Inc Planta Idependencia,Juarez Chihuahua

Job Id: 10001302
Organization:
Ethicon Inc

Recruiter

Anayancy Lozano Martinez

Primary Location:Latin America-Mexico-Chihuahua-Juarez
Organization: E.E.S., S.A. de C.V. Mexico (8283)
Travel:No
Job Function: Quality Control