Quality Systems Documentation Specialist

Title: Quality Systems Documentation Specialist

Location: Scarborough, Maine

Duration: 9 Months

100% Onsite

Shift Time: 8am to 5pm

Job Summary

The position of Quality Systems Documentation Specialist within our Infectious Disease business unit located at Scarborough, Maine. In this role you will perform daily activities required to maintain the electronic Quality Management System (eQMS). This position is also responsible for and participating in the development,implementation, documentation, maintenance, and improvement of the business’s eQMS.

Job Responsibilities

• Serve as site-level system administrator of the Change Control module and various other modules in Agile PLM
• Support implementation of new modules or new software for the QMS
• Manage system user profiles, user groups and role assignments and troubleshoot user issues
• Develop, prepare, implement, and maintain quality system procedures according to applicable standards and regulations
• Process change orders and requests to standard operating procedures (SOPs) and forms.
• Monitor the review and approval of documentation managed through the eQMS
• Develop and coordinate training programs for new and current eQMS users
• Recommend and initiate process improvement initiatives based on identified trends and key performance metrics
• Work under defined timelines and be accountable for completing work within specified time periods
• Other duties as required
  
  

Education

• BS in Engineering, Chemistry, Bio-Technology, Life Science or related discipline or equivalent combination of education and experience
• Two to five years’ experience in the medical device industry, preferably in Quality or Document/Change Control
• Demonstrated proficiency using Microsoft Office applications
  
  

Preferred Qualifications

• 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 (Microsoft Office, Adobe). A working knowledge of Agile PLM or equivalent is preferred.
• Skilled in tasks associated with document handling, archiving and change management
  
  

Consultants Eligible Benefits Upon Waiting Period

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)
  
  

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, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.