Neeline John Email & Phone Number

Toronto, Ontario, Canada

Mississauga, Ontario, Canada

• Responsible for providing clinical readiness support for 5 NPI projects• Reviewed and approved DHF/DMR deliverables for NPI products from early concept phase to post-market surveillance ensuring products meets regulatory, standards, and internal QMS requirements.• Review and approve Risk Management activities such as Risk Management Plan, Hazard Analysis, DFMEA, PFMEA, UFMEA, Risk-Benefit Analysis, and Risk Management Report• Worked closely with contract manufacturers to review and approve process design documents• Reviewed supplier quality agreements and metrics for providing materials and services for product realization activities.• Lead quality initiatives to establish requirements for real-time aging, effectiveness of risk control measures, and design verification templates.• Spearheaded various continuous improvement projects to eliminate documentation redundancies and improve QMS efficiencies meeting goal of 1 CI per quarter.• Applied problem-solving techniques such as 5 Whys, FTA, and fishbone analysis to support non-conformance and CAPA investigations.• Performed other core work tasks such as internal audits, supplier qualifications, remediation activities, and QMS maintenance. • Provide onboarding training on various QMS procedures and topics to new hires as needed.

Toronto, Ontario, Canada

Toronto, Canada Area

- Support MDR recertification projects- Support design and development of stiff guidewires for clinical use- Work closely with contract manufacturers aligning quality requirements

Los Angeles, California

Abbott’s Cardiac Rhythm Management division (formerly St. Jude Medical) is an industry leader in manufacturing Class III Implantable devices such as Defibrillators, Pacemakers, Monitors, Leads, and associated external devices. As a consultant, I was assigned to evaluate the client’s needs to remediate FDA's warning letter and perform the tasks to comply with the latest standards such as ISO 13485:2016, ISO 14971:2012, EU MDR 2017, and IEC 60601-1:2012. Listed below are the highlights of the tasks performed at Abbott:1. Author SOP and DWI for Preliminary Hazard Analysis and Annual RMF Review2. Update existing SOP for Risk Management Procedure and Product Development Procedure to comply with the latest standards3. Prepare templates for all types of Risk Management Files (RMF) such as RM Plan, RM Report, DFMECA, PFMECA, CFMECA, and SRA in compliance with the latest standards4. Perform RMF remediation of existing files using the templates prepared in excel (NPS validated)5. Lead 8-member team to ensure timely completion of the annual RMF review (all product families)6. Participate in design reviews and perform product verification testing. Prepare Design Verification Test Plans and Reports.7. Provide Mechanical expertise in process and test engineering, to design modules to meet product requirements8. Studied and recommended techniques to improve existing products in electrical or mechanical design to meet functional/performance/reliability requirements9. Provide backroom support during FDA, TUV, BSI, and AQR audits

Master’S Degree, Mechanical Engineering

Bachelor Of Technology (B.Tech.), Mechanical Engineering

Activities and Societies: Neuron 2010, Blitzschlag 2011-13