Complaints Analyst I

**Function**- Quality**Sub function**- Customer/Commercial Quality**Category**- Analyst, Customer/Commercial Quality (P4 - N23)**Location**- Ciudad Juarez / Mexico**Date posted**- Mar **Requisition number**- R- **Work pattern**- Fully OnsiteDescription**Job Function**:Quality** Job Sub Function**:Customer/Commercial Quality** Job Category**:Professional** All Job Posting Locations**:Ciudad Juarez, Chihuahua, Mexico** Job Description**:Coordinates and assists with the documenting business critical issues in Customer/Commercial Quality. Applies functional knowledge of Customer/Commercial Quality and identifies regulatory standards and policies that may impact organizational objectives. Assists with routine collection and dissemination of customer feedback, metrics, and key performance indicators to ensure continuous improvement of the quality management system. Carries out processes to ensure internal and key external business partner organization's alignment and fulfillment of quality and regulatory requirements with overall quality priorities, under direct supervision. Follows formal escalation processes to surface issues of product quality, regulatory compliance, and quality systems. Carries out customer handling complaint process, and establishes and maintains Quality System Elements. Analyzes basic research and data related to regulatory changes, external trends, and strategy. Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team. This job does not require any experience. This job is overtime eligible.** 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.**About Cardiovascular**Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.**We are searching for the best talent for COMPLAINT ANALYST I to be in Ciudad Juarez, Mexico.****You will be responsible for**:In accordance with all applicable federal, state and local laws/regulations and CorporateJohnson & Johnson, procedures and guidelines, this position:- 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 customercomplaints.- Establish reports for the prompt review of new complaints, regulatory reporting decisions, andfollow-up.- Develop, establish, prepare, and distribute dashboards and reports to assure complaints areprocessed in a timely manner.- Responsible for coding the event and ensuring that all the required information for a complaint fileis 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 complaintclosure.- Responsible for tracking, receiving, and shipping products as needed.- Execute the complaints analysis and failure investigations daily and document the analysis resultsand 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 wellas other internal departments such as Marketing, R&D, Customer Service, and TechnicalServices.- Write customer response letters, as required.- 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 opport