Lakshmi Priya Manda
Quality Assurance Manager
- Role
- Quality Assurance Manager at Diabetomics Inc
- Location
- Beaverton, OR, US
- LinkedIn followers
- 500 followers
About Lakshmi Priya Manda
I am a Quality and Regulatory leader driven by a simple mission: ensuring that innovation…
Experience
Quality Assurance Manager
Jun 2025 — Present · US
Maintains the quality management system in compliance with ISO 13485, EU IVDR, and 21 CFR 820.Reviews/approves Standard Operating Procedures, Validation Protocols and Reports, Design Change Orders, Deviations, CAPA and Non-conforming Material Reports, and Complaint investigations and Supplier Corrective Action reports, including quality control test results, as needed for the release of product.Works with supply chain regarding contract manufacturers and suppliers to improve quality through pre-qualification reviews, on-going oversight and audit, implementation of engineering changes and other procedures.Evaluates Device Master Files, including Design History Files, Device Master Records, Device History Records, and Risk Files.Maintains an in-depth understanding of the quality and documentation systems, applicable standards and requirements as it related to and impacts development, manufacturing, and distribution.Ensures that all team members are trained in the Quality System.
Education
Northeastern University
Master of Science - MS
Andhra University
Bachelor of Pharmacy - BPharm
Sasi Educational Institutions, Velivennu
Intermediate
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