Project Coordinator # JN -062021-66226

Plymouth, Minnesota
Industry: Business Analyst / Project Manager
Job Number: JN -062021-66226

Title                           : Project Coordinator

Location                    : Plymouth, MN, 55442

Duration                   : 12+ months contract

 

QUALIFICATIONS

  • Bachelor's degree plus 2-5 years of related work experience with a good understanding of specified functional area, or Master's degree with 0-2 years of related work experience, or an equivalent combination of education and work experience.
  • Knowledge of FDA & EU regulations, GS1 and ISO standards preferred.
  • Experience working in medical device industry with focuses on regulatory compliance, quality systems, labeling, or UDI preferred.
  • Experience working with ERP and/or PLM systems preferred. Preferably SAP and/or Windchill.
  • Database management and/or analytics software knowledge preferred.
  • Skilled in Microsoft Office specifically Excel, PowerPoint, Word, and Access

 

Description:

  • Coordinate project deliverables per project plans.
  • Cross functional coordination and management of project deliverables.
  • Create and manage labeling change processes within the document management systems.
  • Work cross-functionally to identify and resolve labeling inconsistencies to meet applicable requirements and project timelines.
  • Performs analysis of Labeling data to support regulatory compliance and cross-functional business requirements.
  • Manages concurrent deadlines and meets deadlines for assigned work/tasks.
  • Analyze and interpret large data sets and identify methods of resolution.
  • Complies to world-wide Labeling and UDI regulations and cross-functional business requirements.
  • Comply with company initiatives in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), FDA & world-wide regulations, business requirements, company policies and operating procedures.

 

 


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