Complaints Analyst I

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

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.

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.
• Escalate critical issues for proper disposition as necessary, and in accordance with the applicable escalation procedures.
• Provide support in the training of the complaints process for new analysts or technicians if the analyst has been identified as a subject-matter expert.
• Investigate and develop solutions related to procedures and process issues.
• Participate in Quality improvement processes and projects.
• 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.

Requirements:

Education:

• A Bachelor’s degree or equivalent is required

Experience and Skills:

Required:

• 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 years of quality, manufacturing, or regulatory experience in medical devices or other regulated industry.
• 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.
• Ability to understand and follow complex written procedures is required.
• Strong written and verbal communication skills. Must be highly proficient in reading, writing, and speaking the English language.
• Familiarity with computers and Windows-based PC applications. Ability to learn and manipulate complex computer system applications is required.