Ricardo Garcia work email
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A Senior Quality Leader who utilizes engineering practices, business analytics, and FDA/ISO regulation to drive successful and decisive quality units. Experienced in the Medical Device and Pharmaceutical Industries with demonstrated research proficiency in neuroscience and prosthetic development. Strong educational foundation with a B.S. in Biomedical Engineering (Biomaterials/Tissues) from New Jersey Institute of Technology and a Masters in Global Engineering Leadership from The Ohio State University.
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Senior Quality EngineerLemaitrePrinceton, Nj, Us -
Adjunct ProfessorNew Jersey Institute Of Technology Jan 2024 - PresentNewark, Nj, UsAs an Adjunct Professor within NJIT’s Biomedical Engineering Department, I am be responsible for teaching and guiding students. The courses I work to develop and deliver are commensurate with my education, industry experience and qualifications (i.e. Fundamentals of Tissue Engineering). Within the role, I focus on contributing to the academic mission and goals of the department. -
Senior Quality EngineerLemaitre 2023 - PresentBurlington, Ma, Us -
Advisory Board: New Jersey Governor’S Stem ScholarsResearch And Development Council Of Nj May 2019 - PresentChatham, Nj, UsAdvising operations of the New Jersey Governor’s STEM Scholars program. The board is made up of STEM Leaders looking to generate and identify STEM opportunities within the state of New Jersey for the many bright minds that we possess. -
Senior Quality Investigation SpecialistAkorn Pharmaceuticals Mar 2022 - Jan 2023Lake Forest, Il, Us• Led and Managed cross-functional departments to perform a comprehensive investigation into deviations, out-of-specifications (OOS), and out-of-trends (OOT) per FDA regulations and cGMP.• Led Critical Investigations, Quality Risk Assessments, and Risk Mitigation Assessments.• Authored deviation reports that are comprehensive, clear, concise, and withstand regulatory scrutiny.• Performed product impact analysis, risk analysis, and product disposition for Operations and Laboratory based deviations.• Worked with contract suppliers, laboratories, vendors, and manufacturers to conduct Supplier Corrective Action Reports (SCARs) and related Corrective Actions.• Tracked and trended non-conformances and recommend additional action, as required, to prevent re-occurrence of the deviation.• Developed Corrective & Preventative Actions (CAPA) to ensure compliance, effectiveness, and to prevent deviation recurrence.• Developed and presented Monthly & Quarterly Metric Reports to the Executive Leadership Team to ensure the effectiveness of Quality Systems• Implemented internal and external audit response plans based on audit observations.• Front-room audit support for investigations, manufacturing, and general quality compliance.• Back-room lead, SME coaching, and audit readiness development planning experience.• Manufacturing and Quality Control (Microbiology & Chemistry/Analytical) method assessment for continuous improvement and quality compliance. -
Quality Investigation SpecialistAkorn Pharmaceuticals May 2021 - Mar 2022Lake Forest, Il, Us -
Team LeaderDexter Finger Prosthetic Sep 2018 - 2023Working towards the creation of an affordable, durable, and dextrous prosthetic for those with Distal Proximal Interphalangeal amputations. My role as a project manager is the coordination of tasks and responsibilities, as well as maintaining the scope, schedule, and budget of the project.I have also taken on the position of a Design Lead. In this, I have been able to execute a design that meets the customer needs while maintaining the design constraints of 3D printing and available materials. This requires knowledge in drafting software and material science to coordinate several aspects of the project cohesively into a functional prototype.
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Quality, Regulatory, & Operations - Rotational AssociateIntegra Lifesciences Jul 2019 - May 2021Princeton, New Jersey, UsQuality Engineer• Ensured Integra Collagen Manufacturing Center Quality Systems and Assurance through Lean Manufacturing approach to 21CFR 820 (QSR) & 210/211 (GMP).• Conducted and Presented Statistical Process Control (SPC).• Led Non-Conformance (NC) Investigation and Corrective/Preventative Action (CAPA) Process Steps to reduce manufacturing process failure.• Led Quality Plan investigation, review, and completion.• Evaluated Risk Assessment investigation to accompany engineering studies.• Led Process Failure Mode and Effects Analysis (pFMEA) updates to current manufacturing practices and failure mode hazard analysis.• Executed Environmental Monitoring Performance Qualifications (EMPQ) for equipment transfer.• Performed data analysis using Excel and Minitab.• Generated SQDC Lean Manufacturing resource to control team project distribution and resource management.• Authored & Executed Equipment Validations (I/O/P Qualifications).• Supported Validation Activities for Requalification, URS, I/O/P QualificationManufacturing Engineer• Evaluated and led manufacturing process investigations to yield and process improvements, cost savings, and achieve quality compliance.• Led investigative problem solving of manufacturing process non-conformances.• Conducted project planning, management, and dynamic team building across internal, external and vendor focused teams.• Initiated Engineering Study protocols for cost saving initiatives and 30% yield improvements.Regulatory Affairs Associate• Maintained international regulatory standards for Codman Specialty Surgical division• Led Technical File remediation activities to harmonized ISO/FDA/MDD/MDR standards.• Performed regulatory agency submission approval and preparation.• Led regulatory action for change control process within Puerto Rico, Ireland, and United States. -
Assistant Engagement CoordinatorNew Jersey Innovation Institute Dec 2018 - May 2019Newark, Nj, Us• Supported end-to-end processes for onboarding NJ hospitals and health systems to NJHIN shared services data platforms to meet NJ Department of Health initiatives, including achieving statewide interoperability through secured patient data exchange.• Conducted project management for NJ hospitals and other healthcare stakeholders to identify information needs, user experience and product workflow to implement health information technology and data integration solutions.• Provided ongoing program development and tracking strategies to streamline business processes and improve adherence to project timelines. -
Chemistry TutorNew Jersey Institute Of Technology Sep 2016 - May 2019Newark, Nj, UsTutoring NJIT students with coursework in both general and organic chemistry -
Provost Undergraduate Summer Research Program 2017New Jersey Institute Of Technology May 2017 - Aug 2017Newark, Nj, UsMy research is on the comorbid effect of alcohol and HIV-1 viral proteins on brain cell interactions. There is a distinct relationship between neurons and the cells that make up the blood-brain barrier (BBB). The selectively-permeable membrane formed by the BBB allows for protection and nutrient delivery to the brain region, via brain vasculature. I focus on these delicate cellular interactions and the effect of introducing alcohol to your system during infection. Find my Published Abstract Here on Page 20:http://centers.njit.edu/uri/sites/uri/files/2017%20Book%20of%20Abstracts%20-%20FINAL.pdfAnd Here on Page 84: http://centers.njit.edu/uri/sites/uri/files/2018%20NJIT%20Book%20of%20Abstracts.pdf -
Health And Human Body InternLiberty Science Center May 2017 - Aug 2017Jersey City, Nj, UsWorking with the Exhibition Leader for Health & Human Body and the amazing team at LSC to design and create lab experiences for guests of all ages.
Ricardo Garcia Skills
Ricardo Garcia Education Details
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The Ohio State UniversityManufacturing Engineering -
New Jersey Institute Of TechnologyBiomedical Engineering - Focus In Biomaterials
Frequently Asked Questions about Ricardo Garcia
What company does Ricardo Garcia work for?
Ricardo Garcia works for Lemaitre
What is Ricardo Garcia's role at the current company?
Ricardo Garcia's current role is Senior Quality Engineer.
What is Ricardo Garcia's email address?
Ricardo Garcia's email address is ri****@****orn.com
What schools did Ricardo Garcia attend?
Ricardo Garcia attended The Ohio State University, New Jersey Institute Of Technology.
What skills is Ricardo Garcia known for?
Ricardo Garcia has skills like Public Speaking, Research, Leadership, Microsoft Office, Management, Microsoft Excel, Powerpoint, Customer Service, Sales, Matlab, Biomaterials, 3d Printing.
Who are Ricardo Garcia's colleagues?
Ricardo Garcia's colleagues are Yvonne Teoh, Trent Antifaev, Pablo Gargallo Soriano, Benjamin Towne, Neeraj Saraswat, Declan Higgins, Moore Henry.
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