Job Description

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 107,000 colleagues serve people in more than 160 countries

JOB DESCRIPTION:

About Abbott

Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions.

Abbotts life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. Were empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbotts diagnostics instruments, providing lab results for millions of people.

Our location in Scarborough, Maine currently has an opportunity for a Electronic Systems Quality Coordinator. 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 businesss Electronic Quality Management Systems.

WHAT YOU'LL DO

* 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

EDUCATION AND EXPERIENCE YOU'LL BRING

Required

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

Preferred

* Familiar with federal and other regulations, e.g. QSRs, 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.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

* A fast-paced work environment where your safety is our priority (Manufacturing roles only)
* Production areas that are clean, well-lit and temperature-controlled (Manufacturing roles only)
* Training and career development, with onboarding programs for new employees and tuition assistance
* Financial security through competitive compensation, incentives and retirement plans
* Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
* Paid time off
* 401(k) retirement savings with a generous company match
* The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully: http://www.abbottbenefits.com/pages/candidate.aspx

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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

JOB FAMILY:

Operations Quality

DIVISION:

ARDx Abbott Rapid Diagnostics

LOCATION:

United States > Scarborough : 10 Southgate Rd

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Yes

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf