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Complaints Analyst I

hace 3 meses

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At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in 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 Move Could Mean Our Next Breakthrough.


At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered and to help people live longer, healthier lives.


In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products and solutions.

We are in this for life.

We are changing the trajectory of human health, YOU CAN TOO.

We are searching for the best talent for COMPLIANTS ANALYST (TEMPORAL 12 MESES) to be in Ciudad Juarez, Mx.

JOB SUMMARY

You will be responsible for:

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

  • Responsible for complaint management (Entry, Follow ups, Product Analysis, Closure, etc.)
  • Possess a thorough understanding of the complaint database.
  • Understands basic principles, theories, concepts, and techniques related to customer complaints.
  • Establish reports for the prompt review of new complaints, regulatory reporting decisions, and followup.
  • Develop, establish, prepare, and distribute dashboards and reports to assure complaints are processed in a timely manner.
  • Responsible for coding the event and ensuring that all the required information for a complaint file is obtained and properly documented to make a final regulatory reporting decision.
  • Evaluates all information from a clinical and technical perspective to ensure appropriate Analysis, Investigation, Root Cause, and Quality Engineering review is documented prior to complaint closure.
  • Responsible for tracking, receiving, and shipping products as needed.
  • Execute the complaints analysis and failure investigations daily and document the analysis results and relevant information to the Med Watch reports in the assigned product families.
  • Approve the complaints in the assigned product families.
  • Set up complaint meetings and effectively communicate with worldwide complaint groups, as well as other internal departments such as Marketing, R&D, Customer Service, and Technical Services.
  • Write customer response letters, as required.
  • Investigate and develop solutions related to procedures and process issues.
  • May receive technical guidance on complex problems, but independently determines and develops approaches and solutions.
  • Participate in Quality improvement processes and projects.
  • Provide support in product transfer and new product development as needed.
  • Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies, Johnson & Johnson Environmental, Health & Safety Practices, and other applicable standards as pertains to medical devices.
  • 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.

Qualifications:

Qualifications and requirements:

  • Complete BS, preferably in computer science, engineering, physical, biological, or natural sciences.
  • Preferably with 0 to 2 to years of quality, manufacturing, or regulatory experience in medical devices or other regulated industry.
  • Preferably American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools
  • Critical thinking and investigation skills are required.
  • Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required.
  • Employee must be able to effectively prioritize and manage multiple activities and responsibilities.
  • Ability to function in a team environment and deliver on team objectives is required.
  • Ability to influence and drive change.
  • Preferably, project management and/or process mapping experience.
  • Strong written and verbal communication skills. Must be highly proficient in reading, writing, and speaking the English language.
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