Manuel Perez
Chemical Engineer | Quality Managment | Quality Assurance | Process Engineer | Medical Devices | EU MDR | QMSR | Continuos Improvement | Project Managment | ISO 13485 | HACCP | Good Laboratory Practices
- Role
- Quality Engineer at Parker Laboratories Inc.
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Manuel Perez
Chemical Engineer with over seven years of experience in quality control systems in the…
Experience
Quality Engineer
Dec 2023 — Present · Fairfield, NJ, US
Successfully led key sections during MDSAP, ISO 13485, and MDR QMS Audits with a new Notified Body, including Quality Management System, Market Surveillance, Design and Development, Risk Management, Process Validations, and Technical Files- Successfully managed the completion of 30+ action items from suggestions made by the auditors during the QMS Audit-Reviewed and updated 34 procedures and instructions related to regulatory, quality, and manufacturing- Managed 3 CAPAs and coordinated QMS audit preparation- Handled registration process across multiple countries, securing approval for 3 product families with SFDA (Saudi Arabia), and additional registrations in Argentina, Kuwait, Peru, and Brazil- Successfully managed and completed 3 product recalls- Facilitated Quality Meetings and Management Review Meetings per Quality Management System requirements-Successfully updated 7 product labels following EPA regulations-Updated and submitted Technical Files for 2 sterile gels, including Design Control, Biocompatibility, Sterility and Design Validations- Led key initiatives for FDA 510(k) clearance of an ultrasound sterile product by developing and managing protocols for image clarity and acoustic measurement testing, chemical leaching risk assessment, rationales, and eSTAR 510(k) submission documentation- Managed Risk Management file updates for 2 sterile products through all phases: plan, analysis, and report- Successfully performed cost analysis for all Parker Products using statistical tools- Analyzed quarterly Environmental Monitoring report data- Monitored and addressed quality trends for conductivity and other parameters-Conducted 3 NCE investigations for product quality issues, leading root cause analysis, performing comprehensive testing protocols, and implementing effective corrective actions.
Education
Universidad Nacional Experimental Politécnica 'Antonio José de Sucre'
Bachelor of Science - BS, Chemical Engineering
2005 — 2011
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