*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.
- performs other duties assigned as needed.
*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.
- 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.
- preferably, prior medical device complaint handling experience, or knowledge of medical.
*primary location*
mexico-chihuahua-juarez
- *organization*
cordis de mexico s.a. de c.v. (8286)
*job function*
engineering
*requisition id*
2206079211w