Hill-Rom QA RA Specialist Post Market Surveillance in Batesville, Indiana
Hill-Rom is a $2.7B leading worldwide manufacturer and provider of medical technologies and related services for the health care industry, including patient support systems, safe mobility and handling solutions, non-invasive therapeutic products for a variety of acute and chronic medical conditions, medical equipment rentals, surgical products and information technology solutions.DescriptionThis role has QA/RA responsibilities throughout North American and global Acute Care (post market surveillance,adverse event reporting, product team support, limited manufacturing and supply chain support, R and D support as required). The role also has responsibility for directing projects/initiatives including directing the activities of cross-functional teams.* Manages complaint workflow and processes complaints within software applications.* Manages potentially reportable event workflow and processes potentially reportable events within software applications.* Determines MDR and Vigilance reportability based on an understanding of the risks associated with product malfunction* Serves as the contact for quality and regulatory related matters once determined there is a quality issue with Hill-Rom product.* Communicates with customers to establish a full understanding of the issues.* Analyzes data (key metrics) for all product development, manufacturing and distribution operations.* Analyzes trends in data for the purpose of initiating corrective actions to resolve or prevent product issues* Identifies, communicates and tracks high priority issues relating to safety, complaints and systemic customer satisfaction.* Enables and recommends rapid and effective correction of quality/regulatory problems in a manner that prevents their reoccurrence.Qualifications* Working knowledge of Quality System Regulation* Experience in resolving issues for internal and external customers* Quality/Regulatory Experience* Experience with QSR, Medical Device Directive, and ISO Quality System Standards* Excellent analytical decision making and problem solving skills* Track record of business and customer orientation* Good computer literacy skills* Good written and verbal communication skills* Good interpersonal, analytical and organizational skills* A.S. Degree in a technical field or 3 - 5 years technical experience or equivalent combination of education and work experience in a specific technical discipline* CQA or CQE desire preferred* Experience in a medical device environment preferred* Ability to define problems, analyze data, establish facts and draw conclusions is requiredHill-Rom is an equal employment employer; F / M / Disability / Vet / Sexual Orientation / Gender Identity img height=1 width=1 border=0 src=http://hillrom.contacthr.com/58167000.jpg /Employer's Job# 58167000Please visit job URL for more information about this opening and to view EOE statement.