Ramon Peña Email & Phone Number

Houston, Texas, United States

Operations Manager in Medical Device Manufacturing of an in vitro diagnostic test device. Responsible for the operations of the manufacturing process, material inventory and control.

Texas, United States

Plans, directs, and coordinates the activities of the maintenance, tooling, and engineering departments, facilitating efficient manufacturing operations across Brevitest Technologies, Inc.

Puerto Rico

Operations & Quality Manager February 2018 to March 2020 (Facility Closed)• Generate revenue by coaching staff and personnel on effective prospecting and lead strategies• Monitor employee productivity and optimize processes to reduce cost• Consistently meet or exceed gross profit goals• Develop safety programs to maintain a record of 0 LTI and 0 RC incidents• Held monthly employee meetings to give information, take feedback, and provide updated training• Waste reduction from 10.8% to 9.7% YTD

Puerto Rico

• Management of quality systems for medical devices related industry. ISO 9001 and 13485. • Proven track record of integrating cost of quality to company quality objectives.• Quality systems improvement by reduce customers and supplier issues. • Compliance with FDA and ISO Standards requirements in product manufacturing.• Machine, Process and Products Validation. • Compliant to company quality objectives improvement. • Non-Conformance Evaluation and Corrective Action Implementation for customer complaint, in manufacturing process and suppliers (5% yearly performance improvement).• Best Quality Index award for Amcor Flexibles Americas in 2018. • Environmental and Safety Compliance Management. Puerto Rico Manufacturers Association –1998 & 1999 OHS AwardREXAM – 1997, 1999 and 2000 Safety Performance AwardAMCOR – 2009 to 2014 Safety Excellence Award for World Class Safety PerformanceAMCOR – Best Quality Index Award – 2018

Juncos & Las Piedras Pr

•Quality Data management for CAPA issuing, evaluation, compliance and trending•Host FDA/ISO/External Audits •Manage Non Conformance Material Report system for compliance, and MRB evaluation•Manage Supplier Corrective Action Request system •Manage the Deviation System and assure compliance with SOP•Chairs the Weekly Compliance Committee, for Management Review Follow Up, CAPA’s, NCMR’s, Compliance Committee Action Items Follow Up, Deviations Status, Internal And External Audits and NCMR’s Status•Use Six Sigma tools in the compliance issues investigations and resolution•Smart CAPA Administrator•Re-validation of process evaluation based on non conformances trending•Tracking of COPQ•ISO 13485 – Plant Certification Support •Manage CRS system Customer Complaints (Las Piedras Plant)•Internal Quality System Auditor ( Las Piedras Plant)

Mba Management, Business Administration And Management, General

Bachelor Of Science In Industrial Engineering, Industrial Engineering