Complaint Handling Manager

Job Description:There may be no better place to advance your career than at Kimberly-Clark. Join our Healthcare Team in a pivotal role of a global consumer and medical products company. Kimberly-Clark is a major global player in health and hygiene products with global-scale issues and opportunities. Please visit our website at to learn more about us.Kimberly-Clark offers a wealth of career growth opportunities that allows you to reach your full potential. You will be able to enhance your skills and chart your own personalized career path. Our collaborative team environment will provide you with an energetic and rewarding work experience that includes project management, technical savvy, customer/supplier interaction and leadership roles. You will have an opportunity to move into other disciplines to broaden your business knowledge. Your technical expertise will enable efficient, timely delivery of name brand innovative products that enhance the health, and hygiene, and well being of families everywhere.Summary:The primary function of the Complaint Handling Analyst is to anticipate, recognize, communicate, and manage product quality issues of worldwide distributed product within Kimberly-Clark Healthcare. The Complaint Handling Analyst is the primary contact for any product quality issue identified by any Kimberly-Clark Healthcare employee, complaint review, complaint investigation, and trend analysis or exception report. In this level position, the incumbent is expected to take a leadership role within the Complaint Handling group and perform his/her assignments with minimal supervision. In addition, the incumbent is expected to make decisions independently and provide clinical guidance when required. Under the direction of the Global Post Market Surveillance Manager, the employee is responsible for monitoring complaint investigations and providing regulatory and clinical input and guidance on the disposition of complaints. Responsibilities: Open and document new complaints in to be managed in the global database Review documentation from incoming calls, faxes, and emails from all areas of the world; responsible for obtaining 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 Evaluate complaints against criteria for potential report ability and elevated to the medical events group as necessary Ensure all required information is obtained and properly documented to make sound regulatory reporting decisions Evaluate 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 Write customer response letters as required. Furthermore, will guarantee all required regulatory reports are completed and reported according to regulatory requirements Record and maintain accurate records of customer complaints in keeping with the requirements of International and Domestic Regulatory Agency requirements Provide available, technically current information to end-users/customers and the sales force in the area of health care products Alerts management to emerging trends in product performance and failures Keeps abreast of new and extended product features Maintains knowledge of product application and common failure modes Serve as a communication link between health care end-users and the business teams, quality assurance, remote manufacturing locations and complaint system users Continually develop and improve the Post Market Surveillance functions to enhance the sector’s image Establish and maintain documented procedures within the area of responsibility as required by the health care internal control planBasic Qualifications: Bachelor’s Degree preferably in Biology, Nursing, Life Sciences, or Engineering Minimum of 2 years of work experience within a medical device manufacturing environment Minimum of 3 years of work experience with medical device complaint handling, investigation, and/or MDR/MDV reporting Solid understanding of the clinical environment and medical terminology is required in order to accurately assess the adverse events associated with device, patient, procedure, and end user A fundamental working knowledge of ISO, FDA, cGMP regulations Expert knowledge of Microsoft Excel, Word, and related software systemsPreferred Qualifications: Six Sigma Greenbelt is desired BSN, RN preferredOther Qualifications: Excellent interpersonal, verbal and written communication skills Self directed work skills and able to prioritize work in a rapidly changing work environment Send your resume today! E-mail (MS Word attachment): Equal Opportunity EmployerClick here to apply via the Kimberly Clark Career Opportunity PortalExpected Travel Time: None