Principal/Project Manager/Senior Quality Engineer
Co-Founder Braulio Ortiz brings more than twenty years of experience in quality assurance, engineering, and manufacturing in the biomedical, pharmaceutical, and medical device industries to BioTeknica. He has extensive experience in design, installation, and continuous improvement of 21 CFR and ISO 9001 compliant quality systems as well as successful outcomes with FDA inspections, Consent Decree and Warning Letter responses. He also has experience developing technical organizations, as well as designing and leading strategic business initiatives. Braulio’s expertise includes quality systems improvement strategies, Six Sigma, Business Process Re-Engineering, facilities commissioning, validation, and cost reduction initiatives.
- Principal, BioTeknica, Inc.
- Represented BioTeknica as member of the third party consultant Implementation Executive Team (IET). The IET managed all the consultant teams and interfaced with Abbott Laboratories Senior Executive team to implement new quality systems and enable Abbott’s diagnostic division to be found in substantial compliance in the successful response to FDA consent decree.
- Assisted in successful response to Consent Decrees and reinspection for medical device clients who manufactured cardiac pacemaker and dialysis cartridges.
- Led successful response to validation related observations found in Warning Letter for a leading pharmaceutical manufacturer.
- Led consultant team that prepared several overseas manufacturers undergo successful FDA inspections and PMA approvals.
- Led validation efforts for various pharmaceutical and medical device operations, including facilities commissioning.
- As Director of Operations for a leading diagnostics manufacturer, led efforts to reduce cost by $3.3 Million/yr., a 28% reduction in standards. Key approaches were product reformulation, activity based cost analysis, and team based organization implementation.
- As Director of Engineering, led efforts to reduce cost by over $7 Million/yr. Key approaches were outsourcing of facilities management, site consolidation, and re-engineering of key business processes.
- Led technical support and quality assurance function for a tabletted product line. Major accomplishments included: (1) $1.1 million/yr. cost reduction through supplier consolidation (and validation of new raw materials) as well as streamlining of product testing based on statistical analysis and sample size rationale, and (2) design and implementation of a Failure Analysis system.
- Developed equipment functional specifications (system requirements), prepared capital appropriation justification, operating and maintenance procedures, installed and validated new equipment.
- Developed engineering specifications and validated facilities, utilities (compressed air, steam, power, purified water), steam and dry heat sterilization units, clean rooms, bulk, filling, and packaging equipment for medical device and pharmaceutical operations.
- Facilitated development of statically valid Master Quality Control Sampling Plan for implantable Class III device manufacturer. Defect classification was driven by Failure Mode & Effects Analysis and test method validation, and process validation was also considered for sampling level.
- Principal/Project Manager/Senior Quality Engineer – BioTeknica, Inc.
- Director of Operations – Dade International, Inc.
- Director of Engineering – Baxter Diagnostic, Inc.
- Quality Systems Manager – Baxter Diagnostic, Inc.
- Manufacturing Manager – American Dade, Inc.
- Project Engineer – American Dade, Inc.
- M.B.A. – University of Miami
- B.S., Chemical Engineering – Cornell University
- Re-Engineering seminar (I.I.E.)
- Quality Function Deployment
- Continuous Flow Manufacturing
- 6-sigma quality/SPC