Complaints Analyst I

**Job Function**:Quality**Job Sub**Function**:Customer/Commercial Quality**Job Category**:Professional**All Job Posting Locations**:Ciudad Juarez, Chihuahua, Mexico**About Cardiovascular**Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.**We are searching for the best talent for COMPLAINTS ANALYST I (TEMPORAL 12 MESES)****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 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.- Escalate critical issues for proper disposition as necessary, and in accordance with the applicable escalation procedures.Other Assignments:- 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 / 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.- 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.- Communication Skills: Strong written and verbal communication skills.- Must be highly proficient in reading, writing, and speaking the English language. Preferably, presentation skills.- Experience with word processor software (e.g. Microsoft Word) and internet browsers (e.g. Internet Explorer) is required. Prefer experience with Enterprise Complaint Management System (ECM).- Preferably, prior medical device complaint handling exp