Job Description

Main responsibilities

Global Quality Systems (CMS, DMS, LMS)

  • Support manage document lifecycle, training assignments, and complaint data entry/analysis.
  • Support administration, maintenance, and improvement of global quality systems.
  • Support initiatives to improve complaint process efficiency, transparency, and alignment across global teams.
  • Actively participate in site and global complaint review meetings, providing improvement insights, driving follow-up actions, and ensuring timely closure.
  • Ensure all documents are managed and stored in compliance with regulatory requirements and company policies.
  • Manage document lifecycle from creation, review, approval, distribution, and archiving.
  • Develop and deliver training programs for employees on document management and learning management processes and systems
  • Provide user support, training, and troubleshooting for system processes.
  • Continuously evaluate and improve document and learning management processes to enhance efficiency and compliance.
  • Work closely with cross-functional teams, including manufacturing quality, commercial quality, design quality and Regulatory Affairs, ensure document and learning management needs are met.
  • Contribute to global projects, automation, and system standardization initiatives.

    • USCAN QMS Support

  • Participate in USCAN complaint reviews, follow-up actions, and closure tracking.
  • Support regional DMS/LMS activities to ensure document compliance and control.
  • Maintain training compliance and readiness for USCAN audits and inspections.
  • Support customer questionnaire
  • Partner with USCAN Quality and Commercial teams to address local QMS requirements.

    • Continuous Improvement & Projects

  • Identify and implement improvements to increase system efficiency and compliance.
  • Support audits and inspections by preparing documentation and evidence.
  • Contribute to harmonization of global and regional quality processes.

    • Required Competence

    Education & Experience

  • Bachelor’s degree in Life Sciences, Engineering, or Quality-related discipline.
  • 5 years of experience in a regulated industry (Medical Device, IVD, or Pharmaceuticals).
  • Direct experience with complaint management, document control, or QMS operations in a multinational or regional setting.
  • Familiarity with ISO 13485, ISO 9001, FDA 21 CFR Part 820, and other applicable regulations.

    • Technical Skills

  • Proficiency with electronic DMS, LMS, and complaint handling tools (SAP, TrackWise, etc.).
  • Experience with data analysis and visualization tools (Excel, Power BI).
  • Strong computer literacy (MS Office Suite).

    • Core Competencies

  • Strong organizational and time management skills, with ability to balance global and regional responsibilities.
  • High attention to detail, accuracy, and compliance mindset.
  • Solid communication skills to work effectively across functions and regions.
  • Proactive, dependable, and able to work independently with limited supervision.
  • Team-oriented and adaptable in a global matrix organization.

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