**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 12 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.
- 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 assigments:
- 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**:
- 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.
be familiar with general quality management system concepts, including good
documentation practice (GDP), corrective and preventive action (CAPA), and document
change control practices.
- 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 regulations.