Internal Auditor Data Entry

Gilbert Pinzon

**** ******* ******

Fremont CA, *4538

Phone: +1-510-***-****

Email: *********@*****.***

SUMMARY

Reliable professional with over 20 years of data entry experience. My technical expertise includes proficiency in MS Office, and ERP-CRM Systems.

EXPERIENCE

Venus Concept, San Jose, CA July 2019 to March 2025

Quality Service Provider

Quality Consultant, MDR/Internal Auditor/Supplier Auditor/Complaint and CAPA Management

Quality Consultant, MDSAP Project Leader, Internal Auditor & Supplier Auditor

Notable Contribution: Venus Concept passed ISO 13485:2016 recertification upgraded to MDSAP

Successful NCMR, Complaint and CAPA remediation project

Successful ISO 13485:2016 recertification with MDSAP upgrade

Currently managing Complaint System

Currently supporting CAPA System

Currently providing Internal Audit support

Currently providing Supplier Management and Supplier Audit (e.g. CMO audit, Sterilizer Audit)

Managed MRB and NCMR successfully

Successful supplier audits. Audited companies:

oNPI, Solutions - Custom Manufacturing Specialists that provide quick turn prototyping, pre-production, production, & turnkey services for a variety of terminations & light duty mechanical assemblies.

oSterigenics Hayward, CA (Gamma Sterilization) - Sterigenics is a global leader in comprehensive sterilization solutions meeting industrial sterilization needs in the medical device, pharmaceutical, advanced applications, commercial, and food industries.

oSteri-Tek - SteriTek is the San Francisco Bay Area and Silicon Valley’s leader in E-beam sterilization and X-ray irradiation for complex products and sensitive materials.

PROCEPT BioRobotics, Inc., Redwood Shores, CA 04/2016 to 07/2019

Sr. Quality Engineer/Internal Auditor

PROCEPT is a Class 2 medical device company that develops a novel minimally invasive technology for the surgical treatment of prostate disease.

Contributions:

o2018: Contributed to successful validation and implementation of PROPEL PLM System.

o08/30/2018: Handpiece One Piece Lean Process Flow successfully implemented.

oApril 2017: Contributed to successful FDA De Novo

FDA have granted the De Novo 510K on 12/21/2017

oContributed to successful ISO 13485 Re-certification with zero observation.

oContributed to successful CE Mark & FDA Registration of CTD and Drape

oContributed to successful 1st Commercial Aquablation Case in Germany

Education:

BS, Business Administration (2007)

University of Phoenix, San Jose, CA

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