FADI SARSAM
San Diego,CA
Summary
Quality assurance personnel with 5 years of experience in developing and implementing quality control systems, enhancing production efficiency, and leading continuous improvement initiatives. Proficient in Quality Management Systems, Lean Manufacturing Principles, and Root Cause Analysis, with a proven track record of reducing defects and improving compliance. Adept at problem-solving, quality assurance, and driving operational excellence in manufacturing environments.
Overview
6
6
years of professional experience
Work History
Quality Engineer II
Bolt Medical
San Diego
08.2024 - Current
- Coordinated and executed Nonconformance (NC), Planned Deviation's (PD)
- Conducted root cause analysis for NC
- Collaborated between manufacturing and Catheter personnel to help improve production results
- Established Quality walk-through program at Bolt medical
- Managed change order processes and approvals, ensuring compliance and continuous improvement within manufacturing workflows
- Lot history records reviewal and release of finished goods
- Onboarding Equipment for production use
- Perform and execute protocols and validation reports
- Established Metrics report program for Nonconformance and IQC
Quality Engineer
Cue Health
San Diego
07.2022 - 06.2024
- Coordinated and executed Nonconformance (NC), Planned Deviation's (PD), CAPA
- Conducted root cause analysis for NC, PD, and CAPA, reducing reoccurrence by 25%
- Introduced over 4000 onboarding equipment to be used in production
- Improving accuracy and reliability of production
- Collaborated between manufacturing automation and bioproduction personnel to help improve production results
- Performed Weekly Audits of Lab, and manufacturing space's and collected data to demonstrate key findings found during the weekly audits to respectable area owners
- Managed change plan processes and approvals, ensuring compliance and continuous improvement within manufacturing workflows
- Worked closely with cross-functional teams to develop and implemented new work instructions and SOPs, leading to significant improvements in manufacturing efficiency
Quality Assurance Supervisor
Cue Health
San Diego
07.2021 - 07.2022
- Prioritized Lot History Record reviewal and release of subcomponent and final product across multiple shifts for bioproduction and manufacturing automation teams boosting production efficiency
- Facilitated comprehensive training programs for manufacturing staff, and Quality assurance personnel fostering a culture of continuous improvement
- Compiled and presented detailed matrix reports to senior management, driving data-informed decisions
- Directed bioproduction/automation personnel across shifts, improving workflow and productivity through streamlined management
- Provided weekly, and monthly one on one within the team across multiple shifts
Quality Control Inspector
Cue Health
San Diego
07.2020 - 07.2021
- Performed incoming quality control inspections on medical device components, assemblies and chemicals
- By conducting visual, dimensional and functional inspections per quality assurance procedures and other specifications
- Ensured measurement, test and inspection equipment is calibrated and in good condition
- Performed in-process, and final inspection of product, packaging and labeling
- Ensure that product, at all stages of inspection, maintains proper identification, traceability, and inspection/test status
- Review and released lot history records/Batch record
- Enhanced inspection protocols, reducing defect rates by 15%, ensuring high product quality and compliance with regulatory standards
- Implemented data-driven quality control measures, resulting in a 20% decrease in inspection time and improved throughput
Sample Management Associate/ Coordinator
Intertek
San Diego
04.2019 - 07.2020
- Responsible for performing all assigned and routine document related tasks in accordance with SOPs and relevant regulatory requirements to include Good Laboratory Practice
- Responsible for receiving, processing, storing, and retrieving project samples appropriately and promptly according to SOPs, all samples must include proper documentation
- Report any discrepancies to the responsible individual and communicate with client if documentation of the sample is missing
- Upload the sample manifest into the appropriate LIM System by manual enter or E-manifest
- Kept freezers with an accurate sample count and organized
- Scrape and clean out freezers as needed to ensure sample integrity and proper functioning
Education
Bachelor's - Biology
Arizona State University
Arizona06.2018
Skills
- GDP
- GLP
- GMP
- Microsoft Office
- Quality Auditing
- ISO 13485 Standards
- ISO 14971 Standards
- 21 CFR 820
- Quality Management Systems
- Lean Manufacturing Principles
- Analytical and Data-Driven Thinking
- Problem Solving and Troubleshooting
- Time Management and Prioritization
- Adaptability and Flexibility
- Quality Assurance and Compliance
- Root Cause Analysis and Corrective Action
- Risk Management and Mitigation
Timeline
Quality Engineer II
Bolt Medical
08.2024 - Current
Quality Engineer
Cue Health
07.2022 - 06.2024
Quality Assurance Supervisor
Cue Health
07.2021 - 07.2022
Quality Control Inspector
Cue Health
07.2020 - 07.2021
Sample Management Associate/ Coordinator
Intertek
04.2019 - 07.2020
Bachelor's - Biology
Arizona State University