Complaint Analyst I

DE&I Statement

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

We are searching for the best talent for Complaints Analyst l to be in Ciudad Juárez (Salvarcar)

Purpose:
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:

- 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

**Qualifications**:

- 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 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.
- Experience with word processor software (e.g., Microsoft Word) and internet browsers (e.g., Internet Explorer) is required. Prefer experience with Enterprise Com