Senior Quality Engineer

• 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.
  

• 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.
  

• 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.
  

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.