Electronic Quality System Coordinator

Job Description

DO WORK THAT MATTERS

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

• Serve as system administrator of Quality Incidents, CAPA, Deviation, Change Control and various other modules within Agile PLM system.
• Support implementation of new modules or new software for the QMS.
• Develop, prepare, implement, and maintain Quality system procedures according to applicable standards and regulations
• Process change orders and requests to standard operating procedures (SOP's) and forms.
• Manage system user profiles, groups and role assignments.
• Monitor the review and approval of SOP's and other documentation managed through electronic quality systems.
• Develop and coordinate training programs, for new and current electronic quality system users.
• Recommend and Initiate process improvement initiatives based on identified trends and key performance metrics.
• Troubleshoot user issues.
• Work under defined deadlines and be accountable for completing work within specified time periods.
• Other duties as required

BASIC QUALIFICATIONS

• BS in Engineering, Chemistry, Bio-Technology, Life Science or related discipline or equivalent combination of education and experience.
• 2+ years’ experience in medical device industry, preferably in Quality or Document Control.
• Demonstrated proficiency using Microsoft Word, PowerPoint, and Excel

PREFERRED QUALIFICATIONS

• Familiar with federal and other regulations, e.g. QSR’s, ISO 13485, CMDR, IVDD/IVDR. Working knowledge of the General Provisions of 21 CFR Part 11 for Electronic Records and Electronic Signatures preferred.
• Advanced proficiency in the use of computerized systems to effectively administer the specialized eQMS applications, as well as efficiently utilize common office applications (e.g. Outlook, PowerPoint, Word, Excel, Visio and Adobe Acrobat). A working knowledge of the ensur or Agile Document Control System software or equivalent is preferred.
• Proficient using the following software systems: Agile and ensur.
• Strong analytical, verbal communication and writing skills
• Ability to work in a team environment as well as independently and with minimal supervision
• Ability to communicate in writing clearly and concisely, using grammatically correct sentence structure.
• Experience in the manufacture and development of product, preferably medical devices.
• Experience with and understanding of medical device quality systems.
• Skilled in tasks associated with document handling, archiving and change management.
• Strong attention to detail and accuracy.
• Strong time management, organizational, and prioritization skills.
• Ability to effectively manage multiple projects and priorities.
• Ability to interface professionally 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 opportunity employer, 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 [email protected].