Senior Quality Consultant
Ruben has more than 25 years of experience in quality assurance, quality control, regulatory, manufacturing and plant operations in the pharmaceutical, combination device and medical device industries. He has extensive experience in microbiology, ETO and steam sterilization, medical devices and inmunotherapy products manufacturing, engineering, process automation, supply chain management, and FDA Quality Systems (QSR) and ISO 13485 implementation. Ruben’s quality experience includes quality assurance labs management, 510 (K) submissions, leading FDA inspections, 483 observations responses, Warning Letter and Consent Decree corrective actions implementation including final product disposition and GMP recertification. His expertise includes microbiology testing, clean rooms design, validation and testing, quality systems and regulatory compliance, plant design and validation, process and sterilization validations, production capacity expansions, process improvements and plant operations management.
- Provided quality systems, quality control and manufacturing operations consulting services to medical devices and pharmaceutical companies.
- Responsible for operations for company that produced pre-filled syringes, disinfection caps and infusion pumps and tubing sets.
- Excecutive subject matter expert for manufacturing processes, sterilization processes and CFR part 820 and ISO 13485 compliance.
- Implemented Quality Systems, obtained ISO 13485 certification and cleared Warning Letter from previous FDA audit. Obtained approval for Sterile Field Flush 510 (K) and low dose heparin pre-filled syringe 510(K’s).
- Implemented company wide quality systems for training, document control, CAPA, change control, customer complaints, design controls, process validations and internal audits.
- Experienced on ISO 10993 – Biological Evaluation of Medical Devices; ISO 14971-2007- Medical Device Risk Management; ISO 17665-Sterilization of Health Care Products-steam.
- Managed the operations and engineering departments for two manufacturing sites and ten (10) plasma collection centers across the U.S. Responsible for plant operations, immunotherapy QC laboratory, microbiology, metrology, supply chain, engineering, maintenance, glassware operations and general facilities administration.
- Managed quality control, red blood cells processing, metrology, microbiology, engineering, maintenance and plant administration. Implemented Quality Systems and supported the regulatory group to obtain the Product License Application (PLA) approval for Nabi HB.
- Supervised the Inmunotherapy Quality Control Unit, microbiology, metrology and ernvironmental monitoring. Supported the Nabi HB and Civacir Inmunoglobulins development during clinical trials and production.
- Managed the chemistry, environmental, metallurgic, sterilization, microbiology, physical and decontamination laboratories, and the document control and quality assurance departments.
- Quality subject matter expert during consent decree for microbiology, ETO sterilization, environmental controls and QC equipment validation.
- Experienced on biocompatibility of long-term/short term implanted devices-completed heart pacers and connector leads testing and evaluation.
- Implemented key quality systems including change control, CAPA, customer complaints and internal/external audit programs
- Responsible for all microbiology testing including sterility, pyrogen, heparin potency, biological indicators preparation, bioburden and environmental monitoring. Also responsible for ETO sterilization cycles validation and revalidation.
- Senior Quality Consultant – BioTeknica, Inc.
- Principal/ Senior Quality Assurance and Operations Consultant – Round Table FE Consultants
- VP of Operations – Excelsior Medical
- QA/RA Director – Excelsior Medical
- Plasma Facilities/Operations Senior Director – Nabi Biopharmaceuticals
- Senior Staff Manager – Quality Services – Nabi Biopharmaceuticals
- Laboratories Senior Manager/Quality Assurance Director – Telectronics Pacing Systems
- Microbiologist/ ETO Sterilization Specialist/Supervisor – Baxter Edwards and Baxter Bentley
- Microbiology Major – University of PR
- Chemistry Minor – Inter-American University
- Lean Manufacturing (Cerfified Practitioner)
- Medical Devices Risk Management (ISO 14971-2007)
- Sterilization of Health Care Products (ISO 17665- parts 1&2)
- Biological Evaluation of Medical Devices (ISO 10993)