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Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.The position of Quality Assurance Product Support Specialist/Field is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will be responsible for managing and maintaining regulatory compliance programs, as well as providing support as needed to other quality assurance functions. This position is expected to provide problem solving skills and critical thinking for investigation and troubleshooting activities. This position is expected to provide field support for remediation of amplicon events at customer sites.This job description will be reviewed periodically and is subject to change by management.RESPONSIBILITIES: Manages the site Customer Complaint Investigation Program, including responsibility for deciding which complaints will be investigated, how they will be investigated, coordinating data generating activities, evaluating data and writing investigation summaries/conclusions. Provides amplicon remediation at customer sites. Provides written summary reports of amplicon remediation activities. Maintains effective communication with Technical Service groups (worldwide locations) regarding this site’s product complaint investigations. Post Market Surveillance; responsibility for assisting with this program. Identify events that may be subject to vigilance reporting requirements and communicate to Regulatory for evaluation. Other duties as assigned.BASIC QUALIFICATIONS | EDUCATION: Bachelor’s Degree in Biology, Chemistry Life Sciences, and or other related technical field or the equivalent education and experience. 1+ years of experience in a Technical Service rolePREFERRED QUALIFICATIONS: Clinical Microbiologist experience 1+ years of experience in a Technical Service role in the medical device industry Prior experience with SalesForce.com Familiarity with amplicon remediation activitiesCOMPETENCIES: Demonstrated ability to manage complex programs, and multiple priorities in a timely manner. Demonstrated ability to analyze data and draw appropriate conclusions. Strong communication skills including accurate technical writing. Proficiency in Database software; Internet software; and Word Processing software. Proficiency in Spreadsheet software. Demonstrated understanding of lab practices. Strong troubleshooting skills relating to amplicon remediation Demonstrated understanding of amplicon and related remediation activities Good working knowledge of medical terminology.An Equal Opportunity EmployerAbbot welcomes and encourages diversity in our workforce.We provide reasonable accommodation to qualified individuals with disabilities.To request accommodation, please call 224-667-4913 or email corpjat@abbott.com
