Assisting Medical device companies with my more than 30 years of experience in Medical device Quality.Assisted PROCEPT BioRobotics in ISO 13485 Registration and getting CE mark for their AquaBeam System

Work with Creganna-Tactx R&D Engineers in assuring the Quality, Reliability and Safety of the Devices being developed for our customers

• Participated in Product Development team, to ensure Design Control process is compliant with GMPs, ISO 13485, ISO 14971, MDD standards and guidelines to develop safe and effective medical devices. Conducted or participated in Design verifications, Risk Aanalysis, Design Reviews, Biocompatibility testing, Aging Validations, and Sterilization Validations• Addressing the customer complaints to ensure compliance with FDA and other international regulations and addresses the customer… Show more • Participated in Product Development team, to ensure Design Control process is compliant with GMPs, ISO 13485, ISO 14971, MDD standards and guidelines to develop safe and effective medical devices. Conducted or participated in Design verifications, Risk Aanalysis, Design Reviews, Biocompatibility testing, Aging Validations, and Sterilization Validations• Addressing the customer complaints to ensure compliance with FDA and other international regulations and addresses the customer satisfaction. Assist in engineering evaluation of returned devices and generate appropriate CAPAs or other Quality system changes.• Oversees system for CAL and PM of tools and equipment. • Managed the supplier Quality program, performing supplier evaluations, updating AVL and auditing Suppliers.• Interacted with regulatory compliance bodies during the absence of QA/RA manager, and managed production quality and document control functions. Show less

• Assisted Oraya in successful completion of ISO13485/MDD assessment of Oraya Quality System and facility.

• Addressing the customer complaints for Neuro Endovascular devices to ensure compliance with FDA and other international regulations and addresses the customer satisfaction. • Assist in engineering evaluation of returned devices and generate appropriate CAPAs or other Quality system changes.• Revamped the complaint system to create an efficient and compliant system that passed FDA and BSi scrutinizes without observations.• Also worked with Product Development teams and acted as… Show more • Addressing the customer complaints for Neuro Endovascular devices to ensure compliance with FDA and other international regulations and addresses the customer satisfaction. • Assist in engineering evaluation of returned devices and generate appropriate CAPAs or other Quality system changes.• Revamped the complaint system to create an efficient and compliant system that passed FDA and BSi scrutinizes without observations.• Also worked with Product Development teams and acted as Internal and Supplier Auditor. Show less

• Addressing the customer complaints for AAA, TAA, Coronary and Peripheral Stent grafts to ensure compliance with FDA and other international regulations and addresses the customer satisfaction. FA team nominated for Medtronic Star of Excellence Award.• Assist in engineering evaluation of returned devices and generate appropriate CAPAs or other Quality system changes.• Participated in Product Development team, to ensure Design Control process to ensure that all field relted issues are… Show more • Addressing the customer complaints for AAA, TAA, Coronary and Peripheral Stent grafts to ensure compliance with FDA and other international regulations and addresses the customer satisfaction. FA team nominated for Medtronic Star of Excellence Award.• Assist in engineering evaluation of returned devices and generate appropriate CAPAs or other Quality system changes.• Participated in Product Development team, to ensure Design Control process to ensure that all field relted issues are addressed in new designs and they are in compliant with FDA, ISO 14971, MDD standards and guidelines to develop safe and effective medical devices. • Acted as a Quality System Trainer for new employees, Sales force and other field employees. Show less

Reviewed and revised the Avantec’s Quality System to be in compliance with FDA’s cGMPs for Combination Devices.

• Reviewed and revised the GVI Quality System to be in compliance with Parts 210 & 211 Drug and Pharmaceutical regulations, along with CFR 21 Part 820 QSR. That means converting the VI Device only system into a Quality system that is compliant for Combination Products.• Set-up the Drug Raw Materials department by hiring the scientists, setting up the Receiving Inspection, Coordinating with contract labs., NCMRs, releasing the Drug Material documents.• Established the CAPA program for… Show more • Reviewed and revised the GVI Quality System to be in compliance with Parts 210 & 211 Drug and Pharmaceutical regulations, along with CFR 21 Part 820 QSR. That means converting the VI Device only system into a Quality system that is compliant for Combination Products.• Set-up the Drug Raw Materials department by hiring the scientists, setting up the Receiving Inspection, Coordinating with contract labs., NCMRs, releasing the Drug Material documents.• Established the CAPA program for Drug Eluting Stent (DES) products.• Managed a group of Quality Engineers and Consultants on various Drug Eluting Stent Product development projects. • Managed the Production Quality at Santa Clara for DES Manufacturing. Addressed Deviations, NCMR, Lot Release. Show less

• Document Control, Product Final Inspection and release, Sterilization and Biocompatibility, Quality System Compliance Audits, and Quality System Training.

• Participated in Product Development teams, to ensure that PPQA process has used GMPs, AAMI, ANSI, ASTM standards and guidelines to develop safe and effective medical devices. Conducted Product and process validations, FMEA, Cpk studies, Design Reviews, Biocompatibility testing, Aging Validations, and Sterilization Validations. Participated from Concept phase to the Market release phase of eight such products.

Started as an Inspector, Quickly rose to Technician and Engineer. Worked with development and release of their pioneering Auto Refractor and Field Analyzer. Also worked on Lens Analyzer, AK, Fundus Camera and STATPAC