Livermore, California, United States
I am a Biomedical Engineer by degree and Quality Engineer by profession. Where a developer takes credit for making the design, it is the QE who follows up to make the design robust, reliable, and (of course!) safe & effective. My interests include - Design Control, Process Validation, Design Verification and Validation, Risk Management.
Responsible for managing design control risk analysis/ management, design verification, standards gap analysis, complaints, equipment calibration, supplier management, and document control.
- Conducted supplier and internal audit of the QMS per QSR and perform gap analysis against the revised version of ISO 13485:2016 - Implemented and maintained all aspects of Quality Management System (design control, document control, Cal/PM maintenance, CAPA, NCMR, etc.) - Review test protocols and reports (sterilization, biocompatibility etc.) for V&V, participate in management reviews, design phase reviews and ISO 13485 audits, perform supplier qualification, manage inventory flow to the manufacturing floor and perform receiving and incoming inspection of device material/components. - Assist the Director of Regulatory and Clinical Affairs with preparing regulatory submissions like De Novo, CE Mark. - Perform OpenClinica database testing which stores and analyzes electronic Case Report Forms (eCRF)
- Proactive participation in the installation and maintenance of the in-house quality management system in accordance with 21 CFR 820 and ISO 14971. - Identify and implement effective document control strategies to support R&D, manufacturing and regulatory activities. - Review SOPs, test protocols, test reports, test methods, NCMRs, and ECOs - Participated in Risk Management activities like dFMEA, uFMEA, and Hazard Analysis to ensure safety and reliability of product.
- Manage and maintain HR employee details on the university database using MS Excel. - Data Entry into the university database.
- Organized and maintained data related to the project on the Learning Management Systems (LMS). - Updated social media by writing blogs and uploading photos on WordPress, Facebook, Twitter, etc. - Transcribed videos and assisted contract manager in documentation of all facets of the project.