**Job Function**:
Quality
**Job Sub Function**:
Customer/Commercial Quality
**Job Category**:
Professional
**All Job Posting Locations**:
Ciudad Juarez, Chihuahua, Mexico
**About MedTech**
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
**We are searching for the best talent for COMPLAINTS ANALYST I (FIXED TERM 18 MONTHS)**
**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 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 / Requirements**:
- Close to completion of college career or recently finished or equivalent experience, 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.
- Experience with word processor software (e.g., Microsoft Word) and internet browsers (e.g., Internet Explorer) is required. Prefer experience with Enterprise Complaint Management System (ECM).
- Preferably, prior medical device complaint handling experience, or knowledge of medical device regulation

📌 Complaints Analyst I (Fixed Term 18 Months) (Ciudad Juárez)
🏢 Johnson & Johnson
📍 Ciudad Juárez