Experience

Praxis Technology

• United States
• Medical Device
• 1 - 100 Employee

• Quality Assurance Manager

  • Apr 2022 - Present



BD

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Senior Quality Engineer

  • Jun 2019 - Apr 2022



Delcath Systems

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Quality Assurance Manager

  • Mar 2018 - Jun 2019

  ● Maintains Quality Management System compliant to ISO 13485:2016 and 21CFR820● Leads team of Engineers and Technicians responsible for validations, non-conforming materials, supplier control, risk management, internal audits, environmental monitoring, bioburden, sterilization, batch release, corrective and preventative actions● Team accomplishments: steam sterilization validation, sealer and packaging validations, thermogravimetric analysis for quantification of coating thickness, implementation of a cloud based temperature monitoring system● Leads Monthly Quality meetings reviewing Key Performance Indicators and Quality Metrics to identify problems before they develop● Lead Quality representative on design change projects● Performs ongoing assessments and routine re-validations of EO and steam sterilization● Validated multiple ISO Class 8 environments● Implemented and improved standard operating procedures including: Quality Metrics, Supplier Qualification & Audits, Nonconforming Product, Change Control, Test Method Validation, Verification & Validation Sampling Plans, Normality Testing, Environmental Monitoring, Pest Control, EU Change Notification, Supplier Quality Agreements Show less

• Quality Assurance Engineer

  • Oct 2015 - Mar 2018

  ● Managed Nonconforming Product: risk analysis, disposition, investigation and corrective actions ● Led and managed Corrective and Preventative Actions (CAPA)● Performed complaint investigations● Managed and developed team of engineers and technicians● Key team member of ISO 13485 transition to 2016 revision● Performed supplier audits for test laboratories, sterilizers and manufacturing subcontractors● Performed internal audits● Monitored bioburden and environmental monitoring data along with establishing alert and action limit criteria● Led process and test method validations which include EO and steam sterilization validations, catheter balloon bonding, carbon filtration media bulk density and particle size analysis, automated vision system for dimensioning multi-lumen tubing, tensile testing of a compliant catheter balloon● Led the implementation of process and design changes which included risk analysis, process validation, design verification, updates to technical file and regulatory filings and drafting design master records, procedures and drawings. Show less



Replication Medical, Inc.

• Quality Assurance Engineer

  • Feb 2012 - Oct 2015

  ● Performed design validations, verifications, and risk analysis for design changes● Maintained product technical files and submitted design changes to notified body ● Performed a risk analysis and revalidation assessment for moving production to a new facility● Performed process validations (EO Sterilization, Steam Sterilization, Gamma Sterilization, Packaging, and Purified Water System)● Maintained validation master plan● Performed PFMEAs for new processes or changes to existing processes● Maintained document control; reviewing and implementing all document change requests● Qualified vendors and performed vendor audits● Performed in process inspections, incoming inspections, and responsible for warehouse control● Maintained complaint files and performed product failure investigations● Generated nonconformance reports and performed failure investigations● Generated and implemented corrective and preventative actions● Trended and analyzed complaints, nonconformities, bioburden, seal strength, water system testing, customer satisfaction measurements, and environmental monitoring data● Maintained calibration and preventative maintenance system; generated equipment failure reports● Working knowledge of ISO 13485, 21 CFR 820 and harmonized standards Show less

• Research and Development Engineer

  • Jun 2011 - Feb 2012

  ● Product development for medical devices and surgical instruments used to treat the spine● Designed, modeled, and developed surgical instruments and equipment used to process implants● Collaborated with vendors to manufacture prototypes, instruments, and equipment● Performed design validation and verification● Worked with surgeons in cadaver labs to develop and refine surgical techniques and instrumentation

• Research and Development Intern

  • Sep 2008 - Jun 2011

  ● Helped develop surgical techniques for an interspinous spacer device and anterior vessel guard● Performed hydration studies, thermoforming studies, seal strength testing, and various other testing and analysis in order to refine manufacturing processes● Machined parts to aid in the testing and processing of implants● Performed market research and literature review for an interspinous spacer device