Complaints Analyst I

hace 5 meses

Ciudad Juarez, México Johnson & Johnson A tiempo completo

At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world. When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough. At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reimagine the way healthcare is delivered and to help people live longer, healthier lives. In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics, and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products and solutions. We are in this for life.

We are changing the trajectory of human health, **YOU CAN TOO.**

**We are searching for the best talent for COMPLAINTS ANALYST II 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 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 Assignments**:

- Investigate and develop solutions to procedure and process related issues.
- May receive technical guidance on complex problems, but independently determines and develops approaches and solutions. Work is expected to result in the development of new or improved techniques or procedures.
- Participate in Quality improvement processes and projects.
- Provide support in product transfer and new product development as needed.
- Support and/or lead CAPA investigations.
- 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 ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
- May be responsible for training other staff members.
- Supports Product Analysis if required.
- Responsible for communicating business related issues or opportunities to next management level.
- Responsible for ensuring 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.
- 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**:
**Requirements**:

- Completed BS, preferably in computer science, engineering, physical, biological, or natural sciences.
- Preferably with a minimum of 3 years of quality, manufacturing, or regulatory experience in a medical

devices or other regulated i

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