Overview
complaints analyst i (fixed term 12 months) – johnson & johnson medtech. This role is focused on maintaining the quality processes associated with product complaint handling, procedures, and controls to ensure compliant processing of complaints in accordance with company procedures and worldwide regulations and standards.
location: ciudad juarez, chihuahua, mexico
job function
quality
job sub function
customer/commercial quality
job category
professional
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. Our cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke.
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
under general supervision and in accordance with all applicable federal, state and local laws/regulations and corporate johnson & johnson, procedures and guidelines, this position:
* 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
trending, escalation & other activities
* escalate critical issues for proper disposition as necessary, and in accordance with the applicable escalation procedures
* 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
* communicate business related issues or opportunities to next management level
* for those who supervise or manage a staff, ensure subordinates follow all company guidelines related to health, safety and environmental practices
* ensure personal and company compliance with all federal, state, local and company regulations, policies, and procedures
* performs other duties assigned as needed
qualifications / requirements
* close to completion of college career or recently finished or equivalent experience, preferably in computer science, engineering, physical, biological, or natural sciences
* preferably 0 to 2 years of quality, manufacturing, or regulatory experience in medical devices or other regulated industry
* asq certification, six sigma experience, and/or knowledge of process excellence tools are preferred
* critical thinking and investigation skills are required
* ability to multitask and understand customer requirements, retrieve relevant information, and respond promptly
* ability to prioritize and manage multiple activities and responsibilities
* ability to understand and follow complex written procedures; familiarity with gdp, capa, and document change control practices
* ability to work in a team environment and drive change; project management or process mapping experience preferred
* strong written and verbal communication skills in english; presentation skills preferred
* professional demeanor on the phone and in email; technical writing and attention to detail required
* computer skills: windows-based pc applications; ability to learn and manipulate complex computer systems
* experience with word processors (e.g., microsoft word) and browsers;experience with ecm preferred
* prior medical device complaint handling experience or knowledge of medical device regulations preferred
seniority level
not applicable
employment type
full-time
industries
hospitals and health care
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