Senior Quality Engineer

Job not on LinkedIn

October 11

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Revvity

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Revvity is a science-based solutions company that leverages innovation across life sciences and diagnostics to improve lives everywhere. The company serves a diverse customer base, including academia, pharma/biotech, clinical laboratories, and healthcare professionals. Its extensive range of products and services includes genomic analysis, clinical diagnostics, cell and gene therapy, drug discovery, precision medicine, and advanced automation solutions. Revvity is committed to empowering scientists with cutting-edge tools and comprehensive solutions to enhance research and development, diagnostics, and clinical testing. With a focus on accelerating time to market while ensuring quality, Revvity is dedicated to revolutionizing next-generation breakthroughs in healthcare and life sciences.

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• 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.

🎯 Requirements

• 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. • 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).

🏖️ Benefits

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development