Edward Musto

Principal Software Quality Assurance Engineer

Role: Principal Engineer, Software Quality at BD
Location: Irvine, CA, US
LinkedIn followers: 500 followers

About Edward Musto

An experienced solutions-driven Quality professional with extensive technical and operational experience in a broad range of FDA regulated design and manufacturing environments. Skilled at development of macro QA processes and addressing specific product and process development problems. Specific technical expertise in design control, risk management, applied statistics, complaint management and verification/validation activities.

Experience

Principal Engineer, Software Quality
BD
Oct 2024 — Present · Irvine, CA, US
Lead executing Software Maintenance Plans for SiMD in compliance with IEC62304 and BD procedures.Provide Product Risk Analysis (PRA) support for commercially released SiMDImprove and create new processes and procedures related to custom manufacturing software used to automate manufacturing processes based on latest industry trends; including IOT, AI and data-driven technologies (Industry 4.0).Assure software used in manufacturing/testing equipment, computerized systems, and spreadsheets have been validated for its intended use according to BD processesDevelop, execute and provide critical review/approval of software validation documentsWork in close partnership with business units to assure software is validated and maintained in a state of compliance to support business operationsEnsure compliance with department and company proceduresTrain and provide guidance to teams on the software validation process

Education

Columbia Engineering
BSME, Mechanical Engineering

Skills

Verification and Validation (V&V)
Quality Control
Spc
Minitab
Medical Devices
Capa
Fmeca
Mdrs
Iso
Fmea
Iso 13485
Fda
Risk Management
Value Stream Mapping
Dmaic
Product Development
Six Sigma
Cross-Functional Team Leadership
Iso 14971
Root Cause Analysis
Test Method Validation
Design Control
Test Methodologies
R&D
Complaint Management
Lean Manufacturing
Gd&T
Validation
U.s. Food and Drug Administration (Fda)
Quality System
V&V
Process Simulation
Design for Manufacturing
Quality Assurance
Design of Experiments
Manufacturing
Testing
Engineering
Statistical Tools

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