Quality Complaint Investigator

Quality Complaint Investigator Apply now "
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Date: Sep 12, 2017
Location: Libertyville, IL, US
Company: Hollister Incorporated
We Make Life More Rewarding and Dignified
Location: Libertyville
Department: Quality
Act as the primary notification and consolidation point for processing, analyzing, and reporting product complaints
Develops and updates company complaint and inspection procedures to ensure capture and investigation of complaints.
Reviews and analyzes database such as SAP and SalesForce.com (SFDC) to identify and report recurring issues
Documents and tracks contact information, reported issues and problems in accordance with Hollister guidelines and external regulatory requirements
Analyze trends and ability to provide recommendations to other departments on potential corrections
Gain product and process knowledge to understand root cause
Generate written reports to document root cause investigation or summarize trends identified
Evaluation of complaint information from systems such as SAP or SFDC for potential non-conformance or reportable (MDR, Safety, etc.)
Collaborate with other internal groups to respond to product inquiries and issues
Ability to conduct investigations within manufacturing sites at a variety of locations
Answer telephone "hot line" and written or Internet-based inquiries regarding company products
Must have manual dexterity (use of mouse, keyboard) ? to type and enter data into a computer
Must be able to sit for prolonged periods of time (6-8 hours per day)
Must be able to stand for significant periods of time (3-4 hours per day)
Must be able to handle multiple prolonged telephone conversations
Bachelor's Degree
Must speak fluent English
Length of experience
Minimum 5 years customer support or similar experience with progressive responsibilities, including training, root cause analysis and problem solving, report generation
Minimum 2 years work experience in a medical device or pharmaceutical market
General awareness of industry regulations (ISO 13485) and cGMPs
Excellent Communication skills ? verbal and written
Experience with Microsoft Office suite
Demonstrated problem solving skills and implementation of new processes
Experience in a team oriented business setting
Willingness to support other quality systems such as auditing and training
Strong organizational skills
Hollister is an EO employer ? M/F/Veteran/Disability

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