Delia Boboi
Quality Assurance Professional, CQE
- Role
- Quality Engineer at STERIS
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Delia Boboi
As a highly experience quality process leader, I have expertise in development and…
Experience
Quality Engineer
Jan 2024 — Present · Richmond, CA, US
Product quality: Improved the warranty data analysis for product failures by reviewing reliability models, cleaning legacy data, improving the labeling of the issues, taking the input of cross-functional departments by identifying clear point of failures and taking actions to fix the failure.Enhanced the product escalation process and brought changes to the Power App process. Familiar with QC tools, statistical process control plans (SPC), analyzed process capabilities, PFMEA, PAPP, APQP, experienced with validation methodologies.Identification and traceability: improve process for components serialization through resource allocation and improved process flow. Change Management and document control: Improved and updated the change management process by working with cross- functional teams for template automation to ensure a full due dilligence is done. Implemented an audit trail feature in excel to demonstrate compliance with data integrity.Technical File: assembled, updated and coordinated technical files for various medical device products by reviewing the current UDIs, bringing updates as applicable to the risk management files. Conducting a periodic post market surveillance and clinical evaluationsNCRs, complaints, CAPA: actively sustained the nonconforming product management activitiesSupplier: Design a system for ASL documents in SharePoint and automized notification systems for due diligence
Skills
- Material Selection
- Autocad
- Mathematics
- Materials
- Iso 14001
- Iso 9001
- Material Flow
- Materia
- Adobe Professional
- Building Materials
- Materials Science
- Microsoft Office
- Solidworks
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