Experience

American PAPR

• United States
• Medical Device
• 1 - 100 Employee

• Quality Engineering/Quality Assurance Manager

  • Apr 2021 - Present



Maquet Getinge Group

• Medical Equipment Manufacturing
• 700 & Above Employee

• Quality Engineering Manager

  • Jan 2011 - Aug 2022

  MAQUET GETINGE (Formerly Datascope Corporation, Cardiac Assist Division) 2000 - 2020Fairfield, NJQuality Engineering Manager 2011 - 2020• Managed team of 6 engineers to support Quality Management System, address non- conformances, corrective / preventive actions, and new product development support.• Composed SOPs and managed approvals through Trackwise DMS, ensuring changes followed best practices.• Improved effectiveness and efficiency of SOPs and policies 10% by following ISO standards and GMP.• Served as Project Lead to validate and implement new sterilization cycles with reduced EO gas concentration, following ISO 11135 standards and ensuring compliance.• Executed CAPA activities, completing Root Cause Analysis (RCA) and Effectiveness Review.• Mitigated risk by planning and conducting internal and supplier quality audits as Lead Auditor.• Upgraded supplier process and product quality through effective auditing.• Oversaw operation and personnel of Quality Control in GMP conditions, enhancing efficiency and effectiveness.• Set accurate schedule for efficient Quality Assurance inspections and audits, improving output by 10%.• Validated sterilization cycles and chamber, verifying compliance to standards.• Reduced inspection time by implementing effective techniques, sampling plans, and complying to ISO quality standards.• Managed projects in R&D, manufacturing, and quality for medical device industry, utilizing excellent organizational, technical, and problem analysis skills and leveraging familiarity with Failure Modes Effect Analysis (FMEA), SPC, and Root Cause Analysis.• Guided completion of biocompatibility study by determining correct study and overseeing conduction by lab.• Controlled EO residuals validation of various product per ISO 10993-7, reducing degassing time by 50%.