Hill-Rom Specialist Quality in Batesville, Indiana
This 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 & 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.
Working knowledge of Quality System Regulation
Experience in resolving issues for internal and external customers
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 required
Primary Location: United States-New York-Skaneateles Falls
Other Locations: United States-Indiana-Batesville, United States-Illinois-Chicago, IL, United States-North Carolina-Cary
Travel Yes, 10 % of the Time
Posting Entity Hillrom
Req ID: 21122248