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We are searching for the best talent for Senior Complaints Analyst I to be in Juarez.
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 (including device testing) 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.
You will be responsible for:
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, follow up, Testing, Closing, etc.).
• Establishes reports for the quick revision of new complaints, report regulatory decisions and follow up.
• Possess a deep understanding of the complaints database.
• Understands basic principles, theories, concepts, and techniques related to customer complaints.
• Develops, establishes, prepares, and distributes dashboards and reports to ensure complaints are processed in a timely manner.
• Responsible of complaint coding and 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.
• Responsible for tracking, receiving, and sending product as needed.
• Execute complaint analysis and failure investigations daily and documents analysis results and information for Med Watch Reports on all product families assigned.
• Approve complaints on all product families assigned.
• 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.Write customer response letters as required. Activities related to Trends and Escalation.
• Escalation of critical issues for proper disposition as necessary, according to the applicable procedures. People management and Talent Development.
• He/she can supervise junior level analysts 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 analysts.
• 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.
• Provide training to new associate Analyst or technician to complaint process as needed.
• 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.
• Participate in process/ quality improvements projects.
• Provides support in product transfers and new products development, as 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 compliance with all Federal, State, local and Company regulations, policies, and procedures Performs other duties assigned as needed.
• BS completed, preferably in computer science, engineering, physical, biological, or natural sciences.
• Preferably, 5 years in quality, manufacturing or regulatory experience in medical devices and other
regulated industry or equivalent combination of experience and education (master’s degree plus 2 years
of experience). Master’s degree is preferred.
• Preferably, American Society for Quality Certification (ASQ), experience in Six Sigma, 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 understand and follow complex written procedures is required. Candidates should be familiar with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices.
• 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.
• Professional demeanor on the phone and in email is required. Technical writing is a routine part of this position. Strong attention to detail is required.
• Required Computer Skills: Familiarity with computers and Windows-based PC applications. Ability to learn and manipulate complex computer system applications is required. 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).
• Prefer prior medical device complaint handling experience, or knowledge of medical device regulations.
• Preferably, ability in measurement and testing equipment.