Beshoi Mansour

• Lead development, execution, and validation of component inspection test methods supporting supplier part qualification and incoming inspection for new and existing products.
• Perform Gage R&R studies to verify measurement system suitability for critical component features based on risks identified in FMEAs.
• Develop and validate optical inspection routines using vision-based measurement systems (e.g., Keyence) to support component qualification activities.
• Design and fabricate inspection fixtures in SolidWorks to enable consistent, repeatable measurements during supplier qualification and inspection.
• Manage component qualification support activities from initiation through closure by validating inspection methods and documenting qualification evidence.
• Evaluate supplier-related nonconformances and contribute to risk-based decisions regarding component acceptance, investigation scope, and follow-up actions.
• Participate in FMEA-driven cross-functional discussions to identify high-risk characteristics and align inspection and validation strategies.
• Support CAPA and deviation investigations by providing measurement data, test method analysis, and technical input toward root-cause evaluation and effectiveness checks.
• Provide engineering support to Incoming / Receiving Inspection, including test method troubleshooting and investigation support.
• Author and maintain test method procedures, SOPs, and work instructions, and support training of inspection personnel.
• Collaborate cross-functionally with Supplier Quality, R&D, Manufacturing, and Operations teams to review, align on, and obtain approval for supplier parts, inspection fixtures, and test method/SOP readiness in support of component qualification and release.

• Supported multiple medical device and biotech clients through on-site consulting engagements, providing validation, quality, and technical support in highly regulated GMP environments.
• Authored and executed IQ, OQ, and PQ protocols for equipment, utilities, and manufacturing systems.
• Applied risk-based validation principles to determine qualification scope, acceptance criteria, and testing depth based on patient safety and product impact.
• Supported supplier-related validation activities by reviewing vendor documentation packages, calibration records, and maintenance histories.
• Investigated validation deviations, identified root causes, and contributed to CAPA strategies and effectiveness assessments.
• Managed change control activities, including impact assessments for clients and system-related changes.
• Compiled comprehensive validation reports documenting execution results, deviations, and conclusions for regulatory readiness.

Client Assignments & Roles

• AbbVie (Irvine, CA) - Validation Engineer Consultant: Supported GMP equipment qualification, deviation investigations, change control, and cross-functional validation activities.
• Biotechnique (York County, PA) - Validation Engineer Consultant: Developed Validation Master Plans (VMPs), executed IQ/OQ/PQ protocols, and supported risk-based validation strategies aligned with FDA and GMP requirements.
• STAAR Surgical (Lake Forest, CA) - Validation CAD Engineer Consultant: Designed CAD-based inspection fixtures, created and updated technical drawings, supported inspection and qualification activities, and interpreted GD&T requirements.

• Supported quality inspection of medical devices, tools, and sub-assemblies in a regulated manufacturing environment.
• Assisted with nonconforming material investigations, inspection reporting, and documentation.
• Supported testing and evaluation of multiple design iterations during product development.
• Created 2D and 3D CAD designs used for manufacturing and production support.
• Authored and executed IQ and OQ documentation, contributing to a 20% improvement in production efficiency.
• Gained hands-on exposure to medical device manufacturing processes, assembly, and inspection operations.