J&J Family of Companies COMPLAINTS ANALYST II in Ciudad Juárez, Mexico
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Cordis is a recognized leader in providing physicians with breakthrough treatment solutions for peripheral vascular disease, a leader in circulatory disease management, interventional cardiology, radiology and electrophysiology products. Today, Cordis employees from around the world share a strong dedication to continue our company's groundbreaking work.
Complaints Analyst II
Will maintain the quality processes associated with product complaint handling, procedures, and controls to ensure that all complaints are processed in accordance with established company procedures and worldwide regulations and standards. Reviews documentation from all areas of the world. Will also obtain adequate information to ensure proper documentation, investigation, and closure of each complaint, in order to make and document sound regulatory reporting decisions/justifications for worldwide reporting. Applies standard practices and techniques in specific situations, adjusts and correlates data, recognizes discrepancies in results, and follows operations through a series of related detailed steps and processes.
You will be responsible of:
•Handling complaints (Entry, Closure, Follow ups, etc.) and writing customer response letters, as required.
•Evaluating 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.
•Setting up complaint meetings and communicating with worldwide complaint groups, as well as other internal departments.
•Establishing reports for the prompt review of new complaints, regulatory reporting decisions, and follow-up.
•Possessing an understanding of the complaint database, as well as basic principles, theories, concepts and techniques related to customer complaints.
•Developing, establishing, preparing and distributing dashboards and reports to assure complaints in process in a timely manner.
•Investigating and developing solutions to procedure and process related issues, and bringing up critical issues for proper disposition as necessary.
•Receiving technical mentorship on complex problems, but independently resolving and developing approaches and solutions. Work is expected to result in the development of new or improved techniques or procedures.
•Supporting and/or leading CAPA investigations and Product Analysis Evaluation.
•Ensuring compliance with the company's Quality System policies and procedures and applicable external requirements and standards, and other worldwide regulatory agencies and other applicable standards as pertains to medical devices.
Reporting to: Staff Quality Engineer
Requirements and Education:
•BS in computer science, engineering, physical, biological, or natural sciences required.
•Minimum of 3 years of quality, manufacturing, or regulatory experience in a medical device or other regulated industry.
•American Society for Quality certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable.
Knowledge and Skill Sets:
•Effective communication skills –verbal and written- in English and Spanish.
•Critical thinking, investigation, strong attention to detail and communication skills.
•Ability to multitask and prioritize activities, including ability to understand customer requirements, retrieve information, and provide responses satisfactorily and with immediacy is required.
•Project management and/or process mapping experience, technical writing skills, as well as comprehension of written procedures and general quality management system concepts, including good documentation practice, corrective and preventive action.
•Ability to function in a team environment and deliver on team objectives, to influence and inspire change.
•Windows-based PC applications, word processor software and internet browsers.
•Ability to learn and manipulate complex computer system applications is required.
•Preferred experience with Siebel Complaint Management System.
Global Leadership Profile Competencies
Integrity and Credo-based Actions lives Credo values; builds trust; tells the truth; initiates clarity into problems; demonstrates genuine interest for people
Collaboration and Teaming puts interests of enterprise above own; works well across functions and groups; forms teams effectively; inspires follower ship; instills a global mindset
Results and Performance Driven assumes personal ownership and accountability for business results and solutions; willing to make tough calls; consistently delivers results that meet or exceed expectations; demonstrates a track record of people development; champions diversity; net exporter of successful talent.
Sense of Urgency actively senses and responds to problems and opportunities; works to reduce "cycle" time; takes action when needed
Biosense Webster Plant
Cordis de Mexico S.A. de C.V. (8286)