Complaints Analyst I

**"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._**COMPANY****COMPLAINTS ANALYST I - (TEMPORAL 24 MESES)****JOB SUMMARY****DUTIES AND RESPONSIBILITIES**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, Closure, Follow ups, etc)- Write customer response letters, as required - Responsible for ensuring all required information for a complaint file is obtained and properly documented to make sound regulatory reporting decisions.- 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.- 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.- Establish reports for the prompt review of new complaints, regulatory reporting decisions, and follow-up.- Possess a thorough understanding of the complaint database.- Develop, establish, prepare and distribute dashboards and reports to assure complaints are processed in a timely manner.- Understands basic principles, theories, concepts and techniques related to customer complaints.**Activities related Trending and Escalation**:- Escalate critical issues for proper disposition as necessary.**Other Assignments**:- Investigate and develop solutions to procedure and process related issues.- May receive technical guidance on complex problems, but independently determines and develops approaches and solutions.- 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 ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.- Supports Product Analysis if 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 compliance with all Federal, State, local and Company regulations, policies, and procedures.- Performs other duties assigned as needed.**Calificaciones**EXPERIENCE AND EDUCATION**- BS in computer science, engineering, physical, biological, or natural sciences required, along with 0 to 2 to years of quality, manufacturing, or regulatory experience in a medical device or other regulated industry or;- High School diploma with a minimum of 4 years of related medical device or other FDA regulated industry.- American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable.**REQUIRED KNOWLEDGE, SKILLS, ABILITIES AND CERTIFICATIONS/LICENSES**- 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 is preferred. Prefer project management and/or process mapping experience.- Communication Skills: Strong written and verbal communication skills are required. Must be highly proficient in reading, writing, and speaking the English language. Prefer developed presentation skills.- Prefer prior medical device complaint handling experience, or knowledge of medical device regulations.**LOCATION**:Juárez, México**Ubicación principal**México-Chihuahua-Ciudad Ju