Luis Cintron Email & Phone Number

Dodge City, Ks, Us

New Brunswick, Nj, Us

Post Market Surveillance Leader and Process owner, accountable for driving harmonized execution across all 12 Johnson & Johnson Medical Device Companies Globally. Responsible for leading improvement projects, hosting external Regulatory Audits, managing vendor relationship, lead QMS integration Activities and provide Regular Update to Executive Board Members.Achievements/RecognitionsThrough Capturing internal customer feedback, lead development team which resulted in improved electronic WW Monthly Recall Report with 72 hours lead time reduction. / Lead several Kaizens workshop to achieved Harmonized Worldwide Recall process resulting in streamlined procedures and practices. / Drove discussion with FDA and EU Health authorities and implemented reportability requirement guidance. / Conducted conversations that allowed to Draft and implement WW Recall Coordinator’s Job Descriptions. / Established Product Issue and Recall Governance monitoring oversight facilitating best practice and benchmarking activities. / Lead 5+ QMS Acquisition & integration Projects. / Implementation Leader for EUDAMED and Manufacturers Online Reporting Environment (MORE) Vigilance Modules. / Spearheaded and implemented a $1.3M GxP project for Electronic Recall Communications which resulted in 98 days lead time reduction, $2.8M cost avoidance and $2M Growth Profit Revenue. / Lead and implemented a $500K GxP project for Worldwide Product Distribution traceability reports which resulted in $900K+ cost avoidance.

New Brunswick, Nj, Us

Post Market Surveillance Manager with responsibility to assess, coordinate, drive discussions and effectively communicate any Product Issue Escalations and Correction/Removals Activities. As well collaborate globally with DePuy Synthes Medical Device recall coordinators and create proactive strategies to ensure customer centric & compliant recall execution. Responsible to implement and monitor Product Issue Escalation Records and Recalls performance metrics.Achievements/RecognitionsLead team in remediation project which resulted in 78% reduction of aged open records. / Successfully implemented Automated Metrics performance tools that has driven 432 hours cost avoidance annually with awarded Benchmark State. / Developed excellent working relationship with FDA and HPRA agencies. / Awarded 22+ times for Excellent execution and Significant Contribution. / Mentored, developed and facilitated promotional opportunities to direct reports.Key Responsibilities:Act as a representative and negotiator for J&J Medical Devices to US FDA, worldwide health authorities and notified bodies, as applicable. / Responsible for direct report supervision and creation, management, and development planning. / Interact with FDA, EMEA and worldwide health authorities & notified bodies on audits, recall notifications and inquiries. / Act at the subject matter expert for US and OUS Recalls during audits / Establish and maintain training programs to execute Recall and FSCA (Field Safety Corrective Actions) Medical Devices with required stakeholders to effectively determine product quality issue resolution. / Support business continuity for Product Issue Escalation processes and Recall for DePuy Synthes / Drive operational excellence of Recall reporting processes and evaluation for Medical Devices.

New Brunswick, Nj, Us

Achievements/RecognitionsSuccessful Cerenovus QMS development, integration and Quality Manual Leader / Lead 88% Reduction in Aging NC’s / Integrated Internal and External Regulatory Standards Management Process / Improved Quality Metrics Analysis Process /2 time Platinum - Encore Award Winner for Outstanding Performance and leadership Managing the PMS-Escalation Process and for Outstanding performance, 2 time Gold - Encore Award Winner for optimizing MD QSMR- Quality Systems Data Review Process and Implementing Future state Operating Model for Integra Divestiture/ 3 Silver Encore Award winner for outstanding performance in MDSAP Audits. Mentored and develop team members.Key Responsibilities:-Established and lead Cerenovus QMS integration & deployment.- NC and CAPA Site lead.-Act as a strategic partner with colleagues in R&D, Clinical Trials, Global Strategic Marketing & Supply Chain to develop and execute global regulatory strategies for new and existing products to assure on-time regulatory approval/clearance and post-marketing activities with a focus on strategic markets.-Responsible for direct report supervision and creation, management, and development plan.-Present monthly and quarterly Quality Management Review meetings to executive & functional leaders-Drive maintenance and improvement to company metrics.-Ensures that the quality aspects for new processes, products and or upgrading of existing processes and products and subsequent Critical to Quality aspects are met-Supports/Initiates investigations for non-conformances.-Provides feedback to operations on problems related to quality and/or compliance.-Supports internal and host external audit programs in front room.-Supports on-going continuing efforts and projects to improve manufacturing Quality Systems & processes.- Ensures Document Control is established and ensures training profiles are assigned and enforced and training administration is established within scope.

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Washington, District Of Columbia, Us

Site’s Senior Quality Assurance Scientist responsible of providing daily oversight and guidance to Miami’s and Kentucky’s Manufacturing Site issues such as: non-conformance evaluation, corrective action evaluation, Batch Disposition activities and Internal/External Audit Support in Front Room /Back Room. QA Lead Representative for projects on: Process Validation, Design Change Review, Risk Management Assessment, New Product Development Launch, Contract Manufacturing activities and Regulatory Assessment. Responsible for coaching daily direct reports on QA Product Release personnel and review Operation documentation supporting Danaher/BCI Quality Core ValuesAchievements/Recognition:Improved in 57% the Non-Conformance Process Evaluation Cycle Time. / Recognition for Improving CAPA Eligibility Process/Recognition for 5C Validation Data Review / Recognition 5 times for Quick Turn Around Documentation /Successful on time Delivery on Aquios New Product Launch and Site Transfer. / Master Control Software Implementation for QA Department / Created 3 Technical Files and Device History File Data Base for 3 New Products / Completion of ASQ Certified Quality Engineer Class / Successful Implementation of Electronic Batch Records. Key Responsibilities:• Represents QA on Current/New Product Research improvement projects and Contract Manufacturing.• In charge of Review/Approval of Non-conformances Reports, process validation documentation,Design and Development Projects, Design Change Plan, Deviation Orders and Design Coach.• Manage risk Documentation; approve Manufacturing Batch Records, Test Methods and Assign/Approve Correction Reports and Corrective Actions.• Review and assure accuracy of product labeling and compliance.• Team with others departments to Facilitate Failure Investigations.• Analyze Complex and Creation of Data Matrix to develop and sustain Quality Metrics Report.• Lead, collaborate and participate in Kayzen Events and Root Cause Analysis.

Washington, District Of Columbia, Us

Microbiologist in charge of running the startup verification, validation and transfer of testing on all manufacturing products of the Single Use System Manufacturing area and other laboratory activities in order to ensure the quality of the products as per current specifications.Achievements/ Recognitions:Two times Award for Service distinction for dedication and Excellence Service by exceeding goals and improving laboratory process and product release. Successful Leader of SUS QC Lab and Clean Room Start Up / Design, validation and initial release of SOP’s for the following tests: BET Detection with Kinetic Turbidimetric/ Microscopic Particle Determination, LAL Gel Clot Bacterial Endotoxin Determination and Gram Stain/Bacterial ID. Successful Product test transfer from Covina, CA to PR facilities. - Determined the Surface Bacteria and Mold monitoring acceptance criteria. - Improve Standard Verification Curve process by reducing to a 50% its cycle process time. - Implemented Product Release Certificate Data Base and Clean Room monitoring Trending Chart - Lead validation of the followings equipment’s: SHIMADZU- TOC, Ultra Microplate Reader and THERMO Scientific refrigerators.Key responsibilities:Perform TOC testing, conductivity, pH and/or particulate cleanliness testingPerform liquid bacterial challenge to filter samples and identify the bacteria isolatedPerform Environmental Monitoring in the ISO rooms, Data entry of the environmental monitoring results and keep annual trendingComplete bacterial endotoxin LAL gel-clot and/or kinetic-turbidimetric and Microscopic Particle Determination test to samplesExecute bacterial Growth Promotion Test Sterility to prepared culture mediaGenerate Laboratory Investigation Reports and Nonconformance’s

Indianapolis, Indiana, Us

Microbiologist specialized in fermentation process and laboratory culture cell of the bacteria E. Coli, responsible of synthesizing the API of the insulin’s Humalog and Humalin.Key responsibilities:• Perform and monitor fermentation process, operate the cleaning process of fermentors and make up tanks, CIP process sterilization, media preparation and dextrose discharge.• Simple trouble shooting in critical process management, preventative maintenance and inspections routine making sure to comply with the Quality Assurance and Regulatory procedures.• Responsible for identifying and supporting Quality Assurance and Regulatory Compliance issues to assure compliance with FDA regulations and process and tanks validations.• In charge of air, steam and dextrose sampling to determine the presence of VOC, DOC and TOC.• In charge of giving assistance to the cell-culture Laboratory in the cleaning, sampling and analyzing processes of the samples to determine the presence of contamination.• Gram-stain and microscopic evaluation of purity- The techniques used to determine the presence of contamination were: TSI, Phenol Red, Eosine Methylene Blue, MAC, TSA and TSB.

Manage chemical reactors responsible for the synthesis, filtration, drying and packaging of MK – 431 the active ingredient of Januvia and Janumet. Achievement: Recognition for improving and sustaining the manufacturing cycle process of the Tank TK-750Key responsibilities:• Award Received: Recognition for improving and sustaining the manufacturing cycle process of the Tank TK-750• Manage the hydrogenation process of the compound, carbon treatment - process following the hydrogenation process-, filtration process and improvement of the cycle time• Responsible for packaging of the final product in the bulk tanks • Management of Plant solid waste and troubleshooting malfunctioning reactor