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Complaints Coding Specialist
Requisition ID: 6363180410
Johnson & Johnson's Family of Companies is recruiting for an Complaints Coding Specialist to be located in Irvine, CA to support our Medical Devices business.
The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.
Atrial fibrillation (AFIB) is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications. 20 million people around the world suffer from AFIB each year. Biosense Webster, Inc. is the global leader in the science of diagnosing and treating heart rhythm disorders. The company established its leadership in electrophysiology with the development of the first real-time, 3D cardiac mapping and navigation technology, as well as the first electrophysiology catheter. The introduction of the company’s CARTO® 3 System in 2009 revolutionized 3D mapping technology by increasing the accuracy, speed, and efficiency of the cardiac ablation procedure.
- Review and analyze assigned customer complaints; and proper investigate the complaint and contact the customer if necessary.
- Evaluate all information from a clinical and technical perspective to ensure appropriate Subject codes, Analysis, Investigation, Root Cause, and Quality Engineering review is documented prior to complaint closure.
- Ensure proper documentation and closure of each complaint in order to make and document sound regulatory reporting decisions/justifications for worldwide reporting.
- Develop, establish, prepare and distribute dashboards and reports to assure complaints are processed and coded in a timely manner.
- Develop a thorough understanding of the complaint database.
- Develop, prepare, and analyze reports for coded complaints on a weekly and monthly basis, as required.
- Escalate critical issues for proper disposition as necessary.
- 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.
- Be responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
- Performs other duties assigned as needed
- A Bachelor’s Degree in computer science, engineering, physical, biological, natural sciences or other related field is required.
- A minimum of 1 year of quality, manufacturing, or regulatory experience in a medical device or other regulated industry is required.
- The basic understanding of engineering fundamentals is preferred.
- Good written and oral English communication skills are required.
- Must be computer literate.
- Continuous interaction with global groups and the ability to collaborate with global customers is required.
- Previous experience with complaints handling is preferred.
- This position will be located in Irvine, CA with regular meetings in Irwindale, CA and may require up to 15% domestic and/or international travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Biosense Webster Inc. (6010)