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Hill-Rom Specialist Quality in Batesville, Indiana

Description

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.

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 required

Job: Quality

Primary Location: United States-New York-Skaneateles Falls

Other Locations: United States-Indiana-Batesville, United States-Illinois-Chicago, IL, United States-North Carolina-Cary

Schedule Full-time

Travel Yes, 10 % of the Time

Posting Entity Hillrom

Req ID: 21122248

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