Richard Batista

• Served as the lead investigator for site-level CAPAs, ensuring regulatory compliance (FDA, ISO 13485).
• Directed strategic initiatives to reduce CPMs, improve dynamic sealing reliability, and eliminate recurrent failure modes.
• Led the creation and institutionalization of Focus Teams to strengthen cross-functional problem-solving culture.
• Oversaw automation initiatives (bottom pivot inspection, membrane leak testing, dynamic seal RPM studies).
• Identified critical gaps in Spinner and Injection Molding processes and implemented sustainable long-term solutions.
• Partnered with corporate and international teams to present findings, defend investigations, and align global strategies.
• Mentored junior engineers in root cause methodology, data analytics, statistical techniques, and project management.
• Delivered high-impact results through process optimization, defect reduction, and robust engineering studies.

• Led major CAPA investigations with full ownership—from initiation to effectiveness verification.
• Directed cross-functional Focus Teams (Spinner, IML, Quality, CI, Maintenance) to address high-impact issues.
• Designed and executed DOEs to optimize sealing conditions, reduce variability, and improve CPK across machines.
• Developed standardized platforms for problem tracking, root cause documentation, and operator learning-curve monitoring.
• Collaborated directly with external partners (Herrmann, KIT, IMS, Pollux) for equipment characterization, CT-scan studies, and automation feasibility evaluations.
• Led technical analysis of bearings, pivots, eyelets, seal rings, and dynamic seal behavior.
• Managed significant engineering studies to eliminate assignable root causes for market complaints.
• Supported URS creation and process validations (IQ/OQ/PQ) for new equipment and upgrades.

• Led independent root cause investigations for recurring defects (membrane sealing, pivot issues, rotor variation, leakage, redness).
• Performed structured analyses using Fault Tree Analysis (FTA), DOE, and statistical tools to identify true root causes.
• Developed action plans and worked with Maintenance, Quality, and Production to implement corrective actions.
• Coordinated with Injection Molding to evaluate cavity performance, dimensional variation, and material behavior.
• Supported implementation of new horns, fixtures, and process parameters for ultrasonic sealing.
• Managed small improvement projects to reduce scrap, rework, and downtime.
• Provided technical training to operators and technicians on defect identification and process discipline.
• Communicated findings to leadership through clear and concise engineering reports.

• Performed daily troubleshooting for quality defects, equipment issues, and process deviations on Spinner and Injection Molding lines.
• Conducted basic root cause analysis using 5 Why’s, Fishbone, and FTA under supervision.
• Supported CAPA investigations by collecting evidence, documenting findings, and executing assigned actions.
• Assisted in data analysis (SPC, CPK, trends) to identify variation in cavities, components, and sealing performance.
• Collaborated with operators and supervisors to understand failure modes during the learning curve.
• Executed validation tasks (sample collection, measurements, test execution) for equipment and process changes.
• Prepared technical reports and supported engineering studies as required.

• Identify quality problems, process deficiencies, and equipment failures, to analyze the root cause of each situation and investigate solutions.
• Create a platform to optimize future problem or quality issues specially with operator in learning curve.

• Ensuring product quality and process stability, implementing new quality management methods, and supporting compliance with production plans.

• Analyze the current state of processes, propose improvement alternatives to increase productivity.
• Enhanced productivity by implementing efficient processes and workflow optimization techniques.