Current Position Opening 

Quality System Specialist 2

This position helps maintain the Loftware Quality System and respond to inquiries about it. 

Job Responsibilities

  • Reviewing quality documents to ensure that they are correct and up-to-date
  • Checking or auditing to ensure that processes are followed
  • Assist with audits
  • Respond to quality system questionnaires
  • Manage individual CAPA projects
    • Assist in the creation of quality documents such as standard operating procedures for varying functions within Loftware
    • Guiding quality documents through the update and approval processes
    • Guide business stakeholders and SMEs through the quality process
  • Assist with administration of QMS supporting systems
  • Support requirements gathering process of verifiable software offerings
  • Other duties as assigned 

Qualifications

  • Strong project management skills
  • Personable, professional and discrete
  • Able to convert verbal information from SMEs (subject-matter experts) into clear and concise written operating instructions
  • Understanding of relevant government regulations such as CFR 21 part 11, Annex 11, and GDPR
  • Focused and task-oriented
  • Strong communication and inter-personal skills and the ability to work with a broad variety of audiences
  • Able to enlist assistance from business stakeholders with minimal interruptions
  • Bachelor’s degree or better in a technical-, business- or communications-related discipline
  • 3 years’ experience supporting a Quality Management System

Pluses

  • Working knowledge of GMP principles
  • Experience with Microsoft SharePoint
  • Experience with Loftware products, particularly Spectrum and SmartFlow 

Loftware, Inc. is the leading supplier of barcode labeling supply chain solutions. Our product line includes sophisticated enterprise-class systems, integration with ERP, MES