Oscar Garcia
Founder and President at QES Medical LLC- Claim this Profile
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English Native or bilingual proficiency
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Spanish Native or bilingual proficiency
Topline Score
Bio
Credentials
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Lean Sigma Green Belt
-Aug, 2013- Nov, 2024 -
ASQ, Certified Manager of Quality/Organizational Excellence (CMQ/OE)
ASQ - World Headquarters
Experience
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QES Medical LLC
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United States
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Medical Device
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1 - 100 Employee
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Founder and President
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Sep 2009 - Present
Main Product: Quality/Regulatory Consulting & Training - Medical Device Industry. ◼ QMS development & support, including implementation of electronic QMS platforms per ISO 13485:2016, FDA QSR 21 CFR part 820, ISO 14971:2019 and 21 CFR Part 11. ◼ Support Design and Development activities. ◼ Medical Device Software Compliance per IEC 62304. ◼ Usability Compliance per IEC 62366-1. ◼ DHF/DDF Development & Support. ◼ Support Verifications and Validation activities. ◼ Support Risk Management activities per ISO 14971:2019. ◼ QMS Audits, including combination product compliance per 21 CFR part 4 and 21 CFR part 210 / 211. ◼ QMS Remediation. ◼ QMS Training. ◼ Supplier Quality Management. ◼ Short and long terms quality team contracts. Show less
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GD Partners LLC
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United States
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Venture Capital and Private Equity Principals
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Founder & Managing Partner
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Jan 2021 - Present
GD Partners LLC is a group of investors who unify forces to maximize profits while supporting advancement in the healthcare industry. GD Partners LLC is an investment fund, which primarily invests in life science companies, including start-ups, which tend to make an enormous impact on the industry through their advancements in science and technology. We also invest in alternative investments; and mutual funds in the US stock market, which provides us the benefit of risk diversification in our investment portfolio. Show less
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Common Sensing
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Quality Director
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Jun 2018 - Feb 2021
Main Product: Medical device for monitoring injectable medicines including transmission of dose events in an electronic format. ◼ Site Quality/ Regulatory leader & management representative. ◼ Creation of all QMS processes per ISO 13485:2016 and FDA QSR - 21 CFR part 820 requirements. ◼ Responsible for the implementation, compliance, and maintenance of the ISO 13485:2016 certification. ◼ Implementation and support of systems to ensure Medical Device Software compliance per IEC 62304 & Usability Engineering compliance per IEC 62366-1. ◼ Successful management of ISO 13485 surveillance audits, as well as internal audits and customer audits, which granted the company the credibility to do business with world class pharma business partners. ◼ Execution of quality assurance in design development and production. ◼ Represents the quality department in business partner interactions. ◼ Update QMS to bring it to compliance to the revised risk management standard ISO 14971:2019. ◼ Manage the resources of the quality department including a Design Quality Engineer, consultants and other team members supporting quality. ◼ Lead the implementation of an electronic document management system (Qualio). ◼ Lead the execution and compliance of all QMS processes, including design controls, production controls, CAPAs, Non- conformance, audit management, supplier controls, assessment of regulatory requirements, etc. ◼ Establish company’s Quality Policy, Quality Objectives and Key Performance Indicators and lead team to ensure compliance. ◼ Lead the management review process ensuring that the metrics support the intent of the Quality Policy and demonstrate that the Quality Management System is suitable and effective. ◼ Coach and development of team members in quality and regulatory matters. Show less
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MicroVision
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NH
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Quality Manager
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Jan 2017 - Jun 2018
Main Product: Ophthalmic medical devices. ◼ Site Quality/ Regulatory Leader & Management Representative ◼ Successful management of audits including FDA inspection resulting in no 483’s ◼ Hands-on quality support to manufacturing ◼ Total overhaul of QMS for compliance to latest standards, including ISO 13485:2016 ◼ Manage successful implementation of UDI compliance program ◼ Technical files updates and maintenance (Post Mkt Surveillance, CER’s, Biocompatibility, Sterilization Validation, Risk MGT Documents, etc.) ◼ Complaints, MDR and EC Vigilance ◼ Manage the resources of the Quality Department including a Quality Engineer, Quality Associates and a QA Inspector ◼ Quality Manager role in sister plant Dutch Opthalmic USA (Distribution Center) in Exeter, NH Show less
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Vention Medical
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United States
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Medical Equipment Manufacturing
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100 - 200 Employee
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Manager, Quality & Regulatory
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2015 - 2017
Main Product: Medical device design, development and contract manufacturer. ◼ Hands-on leadership to the Product Design & Development (D&D) team ◼ Hands-on Quality Support to Product concept through validation and into manufacturing ◼ Manage the resources of the Quality Department including a staff of five Engineers ◼ Product Quality & Regulatory ◼ Intervenes and contributes to successful resolution of technical issues ◼ External, internal and vendor audits Main Product: Medical device design, development and contract manufacturer. ◼ Hands-on leadership to the Product Design & Development (D&D) team ◼ Hands-on Quality Support to Product concept through validation and into manufacturing ◼ Manage the resources of the Quality Department including a staff of five Engineers ◼ Product Quality & Regulatory ◼ Intervenes and contributes to successful resolution of technical issues ◼ External, internal and vendor audits
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Insulet Corporation
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Quality Engineering Manager
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2013 - 2015
Main Product: Insulin Pump Therapy. ◼ Sustaining quality engineering/ process improvements. ◼ Operations quality and receiving inspection. ◼ Complaint management, including streamlining the process resulting in savings of US $1.9 million. ◼ Frequent travel to China to oversee contract manufacturer. ◼ Internal & external quality audits. ◼ Management of a department of 20 people (Engineers, Supervisors Inspectors and Technicians). Main Product: Insulin Pump Therapy. ◼ Sustaining quality engineering/ process improvements. ◼ Operations quality and receiving inspection. ◼ Complaint management, including streamlining the process resulting in savings of US $1.9 million. ◼ Frequent travel to China to oversee contract manufacturer. ◼ Internal & external quality audits. ◼ Management of a department of 20 people (Engineers, Supervisors Inspectors and Technicians).
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Covidien (Medtronic Minimally Invasive Therapies Group)
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Sr. Design Quality Engineer
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2011 - 2013
Main Product: Hemostatic Patch. ● Development of Test Method Validations using Gage R&R and Attribute Agreement Analysis. ● Investigation of product related issues (Cause-and-Effect Analysis, Fish Bone Diagram, etc.). ● Support establishment of Gamma sterilization parameters. ● Design & testing of cold storage sterilization packaging. ● CAPA, NCR, Audits, Calibration, software validation. Main Product: Hemostatic Patch. ● Development of Test Method Validations using Gage R&R and Attribute Agreement Analysis. ● Investigation of product related issues (Cause-and-Effect Analysis, Fish Bone Diagram, etc.). ● Support establishment of Gamma sterilization parameters. ● Design & testing of cold storage sterilization packaging. ● CAPA, NCR, Audits, Calibration, software validation.
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Corindus Vascular Robotics
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Sr. Quality Assurance Engineer
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2008 - 2011
Main Product: Vascular Robotics Medical Device. ● Support building the QMS for a start-up company, including obtaining ISO 13485 certification. ● Writing inspection/test procedures for equipment and product. ● Management of inspections, NCR/ MRB and disposition of materials. ● Internal/external quality audits, DHR review/approval, calibration and other QMS activities.. ● Supplier chain quality: qualification, performance review/ presentation to senior management. ● Support design and development, including software validation. Support IDE submission. Show less
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Accellent
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Laconia, NH
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Quality Engineer
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2007 - 2008
Main Product: Medical device design, development and contract manufacturer. ● Development and implementation of IQ, PQ and PQ protocols and reports. ● Support design transfer activities. ● Development/implementation of SPC, work instructions, FMEA and process validation systems. ● Engineering support for design, manufacturing and quality system. ● Continuous improvement of processes through SPC and process control. Main Product: Medical device design, development and contract manufacturer. ● Development and implementation of IQ, PQ and PQ protocols and reports. ● Support design transfer activities. ● Development/implementation of SPC, work instructions, FMEA and process validation systems. ● Engineering support for design, manufacturing and quality system. ● Continuous improvement of processes through SPC and process control.
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Abbott
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United States
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Hospitals and Health Care
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700 & Above Employee
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Design Transfer Quality Engineer
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2001 - 2004
Main Product: IV Set medical device manufacturer. ● Systems Development/Maintenance to monitor and control of the quality process for new products and changes to existing ones to assure procedures and transfer activities are in place adequately ● Transfer Implementation of 30 New Products into the Mfg floor ● Manage over 100 product changes implementation ● Development of Manufacturing Risk Analysis for Design Transfer Process ● Improvement of process flow for new product introduction ● Other Positions within the Company: Mfg. Quality Assurance Supervisor/ Industrial Engineering Technician/ Process/Validation Engineering Technician Show less
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Education
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2023 -
Harvard Business School
Executive Education - Family Office Wealth Management -
2023 -
Harvard Business School
Alternative Investments -
2013 - 2015
Salem State University
Graduate Certificate in Business, Business Administration and Management, General -
2013 - 2016
Salem State University
Master of Business Administration (MBA), MBA -
1998 - 2002
INTEC
BS, Industrial Engineering
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