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We are searching for the best talent for Complaints Analyst l to be in Ciudad Juárez (Salvarcar) Purpose: Under general supervision, the Complaints Analyst I will be responsible for maintaining the quality processes associated with product complaint handling, procedures, and controls to ensure that all complaints are processed in accordance with established company procedures and worldwide regulations and standards.
This individual will review documentation from incoming calls, faxes, and emails from all areas of the world.
This individual will also obtain adequate information to ensure proper documentation, investigation (including product testing), and closure of each complaint, in order to make and document sound regulatory reporting decisions/justifications for worldwide reporting.
The individual applies standard practices and techniques in specific situations, adjusts and correlates data, recognizes discrepancies in results, and follows operations through a series of related detailed steps and processes.
You will be responsible for : * 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.
Activities related Trending and Escalation: * Escalate critical issues for proper disposition as necessary, and in accordance with the applicable escalation procedures.
Other Activities: * Provide support in the training of the complaints process for new analysts or technicians if the analyst has been identified as a subject-matter expert.
* 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.
* For those who supervise or manage a staff, responsible for ensuring that 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, if applicable * Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures * Performs other duties assigned as needed REQUIREMENTS: * Bacherlor's Degree completed * 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 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.
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.
* 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).
* Preferably, prior medical device complaint handling experience, or knowledge of medical device regulations.
