.**We are searching for the best talent for Complaints Analyst I to be in Juarez.****Purpose**:**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: Activities related Complaint Handling:- 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 follow-up.- 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.- 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.**Qualifications**:**Qualifications and requirements**:- Completed 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
