Senior Complaints Analyst - Ciudad Juarez, México - Johnson & Johnson

Johnson & Johnson

Empresa verificada

Ciudad Juarez, México

hace 2 semanas

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee

Descripción

"Johnson & Johnson companies are equal opportunity employers"

At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity.

Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years.

Regardless of your race, belief, sexual orientation, religion or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.

When You Join Johnson & Johnson, Your Next Move Could Mean Our Next Breakthrough.

SR COMPLIANCE ANALYST

JOB SUMMARY:

Under minimum supervision, the Complaints Analyst Senior will be responsible of maintaining the quality of the processes associated with the handling of complaints of a product, procedure and controls to ensure that all the complaints are processed according to the processes established by the company and the regulations and standards worldwide.

This person will check the documentation of the incoming calls, faxes and electronic mail of all areas of the world.

This person will also obtain adequate information to ensure the correct documentation, investigation and closing of every complaint, with the purpose of taking and documenting report regulatory decisions/justifications for the worldwide report.

The person applies standard practices and techniques in specific situations, adjustments and correlations of information, recognizes discrepancies in the results and follows operations through a series of detailed steps and processes.

DUTIES & RESPONSIBILITIES:

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

Is responsible for the complaint management (Entry, closing, follow up, etc.).
Write customer response letters as required.
Responsible of ensuring that all the information required for the complaint file is obtained and properly documented to make sound regulatory reporting decisions.
Evaluates all the information from a clinical and technical perspective to ensure appropriate analysis, investigation, Root Cause and Quality Engineering review is documented prior to complaint closure.
Set up complaint meetings and effectively communicate with worldwide group of complaints, as well as other internal departments such as Marketing, R&D, Customer Services and Technical Services.
Guarantees that all the regulatory reports required are completed and reported according to the regulatory requirements.
Establishes reports for the quick revision of new complaints, report regulatory decisions and follow up.
Possess a deep understanding of the complaints database.
Develops, establishes, prepares and distributes dashboards and reports to ensure complaints are processed in a timely manner.
Understands basic principles, theories, concepts and techniques related to customer complaints.

Activities related to Trends and Escalation

Escalation of critical issues for proper disposition as necessary

People management and Talent Development

He/she can supervise junior level engineers and/or technicians
In his role of supervisor, he/she plans, develops, coordinates and directs projects with different levels of complexity.
In his role of supervisor, he/she plans, develops, coordinates, mentors and directs technicians and junior level engineers.
He/she is responsible for ensuring that the subordinates follow all the guidelines of the company related to Health, Safety and Environment, and that all the necessary resources are available and in good conditions

Other assignments

Researches and develops solutions for situations related to procedures and processes.
Provides a technical guide for complex problems.
May lead CAPA investigations.
Provides support to internal/external audits, when required.
Ensures the compliance with the policies and procedures of the Quality System and the external applicable requirements and standards, including: FDA, ISO 13485, CMDCAS, PMDA and other regulatory agencies worldwide, Environmental, Health and Safety practices of Johnson & Johnson and other applicable standards that belong to medical devices.
Responsible for ensuring the personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and environmental.
Provides support to the Product Analysis Evaluation, when required.
Responsible for communicating business related issues or opportunities to next management level
Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
Responsible for ensuring personal and Company c