Complaints Analyst I

hace 2 semanas

Ciudad Juarez, México Johnson & Johnson A tiempo completo

**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.

**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.

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