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Abbott Electronic Quality System Coordinator in Westbrook, Maine

DO WORK THATMATTERS

At Abbott, diverse ideas, perspectives, and expertise allow us to create life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.

We have an exciting opportunity for a Electronic Quality System Coordinator within our Abbott Rapid Diagnostics business located at Scarborough, Maine In this role you, will perform daily activities required to maintain the electronic Quality Management System. The incumbent in this position will also be responsible for and participate in the development, implementation, documentation, maintenance, and improvement of the business’s Electronic Quality Management Systems.

Abbott Rapid Diagnostics (formerly Alere) 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.

RESPONSIBILITIES

  • Serveas system administrator of Quality Incidents, CAPA, Deviation, ChangeControl and various other modules within Agile PLM system.

  • Supportimplementation of new modules or new software for the QMS.

  • Develop,prepare, implement, and maintain Quality system procedures according toapplicable standards and regulations

  • Processchange orders and requests to standard operating procedures (SOP's) andforms.

  • Managesystem user profiles, groups and role assignments.

  • Monitorthe review and approval of SOP's and other documentation managed throughelectronic quality systems.

  • Developand coordinate training programs, for new and current electronic qualitysystem users.

  • Recommendand Initiate process improvement initiatives based on identified trendsand key performance metrics.

  • Troubleshootuser issues.

  • Workunder defined deadlines and be accountable for completing work withinspecified time periods.

  • Otherduties as required

BASICQUALIFICATIONS

  • BS in Engineering, Chemistry,Bio-Technology, Life Science or related discipline or equivalentcombination of education and experience.

  • 2+years’ experience in medical device industry, preferably in Quality orDocument Control.

  • Demonstrated proficiencyusing Microsoft Word, PowerPoint, and Excel

PREFERREDQUALIFICATIONS

  • Familiar with federal andother regulations, e.g. QSR’s, ISO 13485, CMDR, IVDD/IVDR. Workingknowledge of the General Provisions of 21 CFR Part 11 for ElectronicRecords and Electronic Signatures preferred.

  • Advanced proficiency in theuse of computerized systems to effectively administer the specialized eQMSapplications, as well as efficiently utilize common office applications(e.g. Outlook, PowerPoint, Word, Excel, Visio and Adobe Acrobat).A working knowledge of the ensuror Agile Document Control Systemsoftware or equivalent is preferred.

  • Proficient using thefollowing software systems: Agile and ensur.

  • Strong analytical, verbalcommunication and writing skills

  • Ability to work in a teamenvironment as well as independently and with minimal supervision

  • Ability to communicate inwriting clearly and concisely, using grammatically correct sentencestructure.

  • Experience in the manufactureand development of product, preferably medical devices.

  • Experience with andunderstanding of medical device quality systems.

  • Skilled in tasks associatedwith document handling, archiving and change management.

  • Strong attention to detailand accuracy.

  • Strong time management,organizational, and prioritization skills.

  • Ability to effectively managemultiple projects and priorities.

  • Ability to interfaceprofessionally at all levels of the organization.

About Abbott

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

An equal opportunityemployer, Abbott welcomes and encourages diversity in our workforce.

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

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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