Senior Quality Engineer

19 hours ago

Thane, India Revvity Full time

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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