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Abbott Senior Product Support Specialist in Charlottesville, Virginia

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 Senior Product Support Specialist is within our Alere Informatics business located in Charlottesville, Virginia. This role will lead and have responsibility for the complaint escalation process, provide product and technology support solutions to customers, and support resolution of on-market product quality issues. The position will operate under supervision and require to work collaboratively while also responsible for independent decisions within broad parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the quality system and consistent with regulatory requirements and business objectives.

RESPONSIBILITIES:

  • Responsiblefor leading the complaint escalation process, includingdocumentation, coordination of investigation, determination of risk, root causeand corrective and preventative actions.

  • The liaison betweenOperations/Support and Software Development teams to facilitate and coordinateresolution activities for on-market product quality issues.

  • Ableto assess a customer complaint for Medical Device Reporting requirements.Identify and escalate cases with potential regulatory actions. Advisemanagement of significant product issues and unresolved customer issues.

  • Managesthe decision-making process and creates a work environment that supports teameffectiveness.

  • Participatesand on occasion leads team through investigations, risk assessments andcorrective actions of CAPAs.

  • Participatesin defining Quality requirements within the design transfer, design control andimprovement project teams.

  • Consultsto ensure that product safety and efficacy have been evaluated and issuesrelated to safety/patient results are elevated for risk evaluation.

  • Ensurescomplaints and nonconformances meet the requirements listed within theoperating procedures.

  • Evaluatescomplaints and nonconformances for product impact, completion of corrections,need for further investigation; and need for global action. Recommend revisionswhere deficiencies are found.

  • Assistsin generating metrics to demonstrate timely completion of the activities listabove supported by regular status reports to Quality Manager and interestedparties.

  • Regularlyanalyses Complaint records and On-Market Surveillance studies to identifytrends. Report Trends, with recommendations via Quality Trend Review andManagement Review

  • Providesassistance to customers including problem solving, and technical informationregarding the use of software applications.

  • Providesthe highest level of escalated support concerning the operation all Informaticproducts.

  • Determinesurgency level and communicates accurately with key stakeholders.

  • Reviewsfunctionality of how our software works when product issues are received.

  • Maintainscustomer requests in Salesforce and tracks the progress of the incident throughto resolution.

  • Keepsinformed and promotes awareness of all product changes.

  • Highlightsissues and presents possible resolutions. Seeks additional information whenproblem is beyond area of personal expertise.

  • Activelyparticipates in development and implementation of new systems/applications.

  • Contributesto the creation of the team's objectives, accepts team decisions and workstoward their implementation displaying sensitivity to group dynamics,

  • Understandsand is aware of the quality consequences which may occur from the improperperformance of their specific job. Has awareness of device defects that mayoccur in their area of responsibility, including product design, verificationand validation, manufacturing and testing activities.

BASIC QUALIFICATIONS | EDUCATION:

  • Bachelor's Degree inScience or Engineering or related technical discipline and at least 5+ years ofexperience technical product support role.

  • 8+ years in aregulated environment, preferably in medical devices with excellentunderstating and knowledge of quality system processes

  • Understanding andexperience with Software Development Lifecycle Management,

Agile methodology preferred.

  • Experience withSalesforce, TCP/IP, VPN Connectivity, Networks, IIS, HL7 interfaces, emailclient programs and protocols, VMWare, Crystal Reports, SQL Server, Medicalterminology, HTML and XML.

PREFERRED QUALIFICATIONS:

  • Strongproblem-solving skills and necessary persistence to work around “roadblocks”.

  • Reviews and analyzesdata, draws effective conclusions. Understands experimental design. Can applyknowledge to data analysis and problem-solving situation.

  • Strong penchant forasking questions and a natural curiosity to understand the root cause of a technicalissue.

  • Ability to work in afast-paced environment, handling multiple assignments simultaneously whileensuring the customer’s issue has been addressed properly.

  • Directly confrontsrather than avoids conflicts, depersonalizes conflict situations by focusing onissues rather than personalities and actively searches for win-win solutions.

  • Excellent listeningskills with the ability to manage challenging customer interactions.

  • Ability tocommunicate effectively with customers in a courteous and professional manner.

  • Appropriatelyinfluences others to support a course of action. Influences activities withoutreliance on formal authority. Removes barriers that block goal attainment anddrives change through the organization;

  • Ability toprioritize workload to ensure critical issues are handled in a timely manner.

  • Demonstratesaccountability for complying with Quality System requirements.

  • Committed toimproving quality and performance of all Informatics products.

  • Exhibit professionalbehavior with both business associates that reflects positively on the companyand is consistent with the company’s policies and practices.

  • Understands and isaware of the quality consequences which may occur from the improper performanceof their specific job. Has awareness of device defects that may occur in theirarea of responsibility, including product design, verification and validation,manufacturing and testing activities.

COMPETENCIES:

  • Focuses on Customers - Promptly and effectively handles issues andproblems.

  • Focuses on Customers - Role models qualityexcellence, continuously improving for our customers.

  • Drives for Results -Is resourceful, leverages resources, tools and technologies in order to be moreeffective and efficient.

  • FostersCollaboration - Avoids getting stuck in a “one right way” approach – remainsopen minded to new ideas.

  • FostersCollaboration - Actively develops a network to bring best solutions to the teamor customer.

An equalopportunity employer, Abbott welcomes and encourages diversity in ourworkforce.

We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please send an email to myrecruiter@alere.com

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

An Equal Opportunity Employer

Abbot 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

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