Senior Quality Engineer
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Monthly Salary:
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Title
Senior Quality Engineer
Location(s)
Mumbai - Remote (Home Based)About Us
Revvity is a developer and provider of end-to-end solutions designed to help scientists researchers and clinicians solve the worlds greatest health challenges. We pair the enthusiasm of an industry disruptor with the experience of a longtime leader. Our team of 11000 colleagues from around the globe are vital to our success and the reason were able to push boundaries in pursuit of better human health.
Find your future at Revvity
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
- Bachelors 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.
Required Experience:
Senior IC
Key Skills
About Company
Learn more about Revvity´s solutions for (automated) nucleic acid isolation from diverse sample materials based on the unique chemagic™ technology.
