Gerardo Gaspar
Digital Systems and Communication Engineer
San Angelo,TX
Summary
Highly motivated, proactive and goal-oriented professional with 11 years of work experience; 8 within the Medical Industry. Proficient knowledge of quality, manufacturing, compliance and customer service. Eager to continue planning, coordinating, and performing activities that support product development and business operations. Efficient while working in both individual and collaborative environment while maintaining a high‐quality work performance.
Overview
11
11
years of professional experience
3
3
Certifications
2
2
Languages
Work History
Senior Manufacturing Supervisor
Ethicon
07.2022 - Current
- Responsible for providing technical expertise and leadership for daily manufacturing operations and ensuring established metrics (Safety, Quality and Compliance, Production Waste, Efficiency, Cycle Time and Continuous Improvement) are met
- Lead production personnel and collaborates with support functions to meet or exceed the goals and objectives of the Business Unit and in alignment with those of the Plant and the Franchise.
- Responsible for ensuring adherence to Environmental, Health and Safety policies and procedures; provides support to ongoing initiatives related to safety and ergonomics programs.
- Guaranteed that manufacturing activities are performed in compliance with the Quality System and drives efforts to enhance a culture of quality and compliance
- Improved product quality through rigorous monitoring of production processes and strict adherence to quality control standards.
- Collaborated with cross-functional teams to address production challenges, streamline processes, and improve overall performance.
- Developed strong relationships with vendors and suppliers to negotiate favorable contracts, ensuring cost-effective procurement of materials.
- Worked on complex investigations and coordinates technical teams to ensure sound experimental design, effective data analysis, identification, execution and implementation of CAPA, NonConformance, and subsequent closure of investigations, with emphasis on external standards and regulations management.
Senior Quality Assurance Engineer
Flextronics Ltd
07.2021 - 07.2022
- Contributed to continuous improvement efforts by analyzing post-release data and identifying areas for process optimization.
- Maximized resource utilization by developing a prioritized risk-based testing approach for each project phase.
- Reduced product defects by designing and executing detailed test plans, incorporating manual and automated testing methods.
- Improved software quality by developing and implementing comprehensive test strategies for new products and features.
Quality Engineering Engineer
Ethicon Inc. - QA Engineering Department
6 2019 - 06.2021
- Supported quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
- Reviewed and analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and other improvement tools and programs.
- Conducted benchmarking with external companies or internal sites to develop more effective methods for improving quality
- Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
- Reviewed and analyzed whether current product and processes (including actions or decisions conducted) are in compliance to standards such as the QSRs, ISO 13485, etc.
- Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
- Conduct periodic line audits to assess for production controls such as lot segregation. Reviewed results of area audits to ensure that corrective and preventive actions are adequate.
- Supported and Approved Equipment, Process and Software Validations (IQ, OQ, PQ, TMV, CSV)
- Partnered with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges are considered when implementing at a supply chain level.
- Supported the development of quality strategies related to the transfer of products, materials and components within J&J or externally.
- Conducted strategic planning with site leaders and Product Engineering Team. Took Partnerships with other functions to establish business priorities and resource allocation.
- Supported audit preparation activities (auditor logistics, front room/back room arrangements, identifying/preparing SME's, etc.)
Principal Quality Engineering Technician
Ethicon Inc. - QA Engineering Department
01.2019 - 06.2019
- Supported the development of quality strategies related to the enhancement and improvement of products, materials and components within J&J.
- Supported the development and execution of design changes.
- Supported Master Data Management (MDM) harmonization strategy for the introduction of new codes.
- Conducted investigation, bounding, documentation and review of non-conformances, Corrective and Preventive Actions (CAPAs). Escalation of quality issues as appropriate.
- Reviewed/analyzed the effectiveness of Corrective and Preventive Actions (CAPAs) and Audit Observations and other improvement tools and programs.
- Accountability and ownership of Quality metrics including maintenance and revision of leading and lagging indicators.
- Ownership and accountability of risk assessment process conducting, documenting, reviewing and maintaining current risk and hazard analysis documentation such as Process FMEAs given product/process changes.
- Supported protocol of Test Method validation and/or Equipment validation.
- Performed Device History Records revisions for processes under validation.
- Coordinate, lead and execute validation activities for the Robotic Ethicon Curvature Needle Tester (ECNT)
Senior Quality Engineering Technician
Ethicon Inc. - QS Department
05.2017 - 12.2018
- Provided training, as required, to associates and peers in areas such as, manufacturing processes and systems applications.
- Assisted, executed and/or owned failure investigations of non-conformance, audit findings, CAPAs, as required.
- Performed data collection and analysis, creating and distributing reports for quality metrics, initiatives, and/or plant scorecards.
- Provided and maintained availability of applicable supplies for the department.
- Maintained and provided information such as quality records from the company's quality information systems
- Acted as local Corrective and Preventive Actions (CAPA) administrator of the quality systems for the Ethicon Juarez Plant.
- Participated in the development of new quality information system applications and processes.
- Responsible in complying with Good Manufacturing Practices (GMPs), Regulations, International Standards, Environmental, and Health Policies
- Compliance with safety policies and procedures.
Process Excellence Technician
Biosense Webster - PEDepartment
10.2016 - 05.2017
- Supervised and implement 5's methodology in 3 new STSF production lines.
- Developed time and space-saving studies to increase and sustain the capacity of a line by creating a One-piece-flow culture based on the Lean principles.
- Theoretical and Practical Lean training to associates, if required.
- Supported, executed and participated in the logistics for the conversion of two product lines (ST/STSF Flexibility project)
- Participated and/or lead daily meetings with group leaders and associates to evaluate the daily performance of the production line.
- Maintained, improved and innovated production line process for the Flexibility Project.
- Performed Microbiology Laboratory Assessments (MLA) to introduce new production lines.
Customer Logistics & Planning (CLP) Co-Op Associate
BOSCH Group - CLPDepartment
09.2015 - 08.2016
- Reviewed and updated warehouse procedures based on the ISO_TS_16949.
- Provided training, if required, to all associates and staff in the principles of Security, Quality, Cost and Delivery.
- Collected and updated the CLP key performance (KPI's) and continuous improvement processes indicators (POINT CIP) at Omega's warehouse.
- Supervised and established goals for associated based on product demand.
- Supported failure investigations of non-conformances, audit findings and product complaints..
- Executed shipping and receiving of raw materials, purchased parts and finished goods.
- Coordinated, if requested, production meetings to deliver client commitments within a timely manner.
- Manage quarantine area process (disposal and/or rework of raw material & FG's).
- Coordinated inventory activities such as: handling low inventories, cycle counts, inventory currency, inventory backflush.
- Supervised the correct handling of FG and raw material through FIFO.
- Created, maintained, updated and supervised data base for all In-Process Quality Instructions (PQI).
- Provided training, if required, to associates in areas such as, manufacturing processes, product complaints, and metrics.
PCSL Assistant Coordinator
Bishop's University - CSLDepartment
04.2013 - 05.2014
- Supervised computer science laboratory.
- Performed preventive and corrective maintenance to all computer laboratory software.
- Repair and maintain all equipment, electronic and electrical components of the laboratory.
- Material Inventory.
- Prioritized tasks effectively under tight deadlines while maintaining a strong attention to detail throughout all aspects of work responsibilities.
- Forged strong relationships with both internal colleagues and external partners through regular communication and excellent interpersonal skills.
- Facilitated communication between project stakeholders, fostering positive relationships and efficient problem-solving processes.
- Managed schedules for multiple projects, ensuring timely completion and client satisfaction.
- Played a key role in the planning and execution of conferences, resulting in successful networking opportunities for attendees.
Education
Bachelor of Science -
Universidad Autónoma De Ciudad Juárez
Juarez, CHIH 08.2011 - 2016.05
Associate of Science -
Bishop's University
Sherbrook, QC, Canada 04.2013 - 2014.05
Skills
Collaboration
Written Communication Skills
Leadership
Adaptability
Root Cause Analysis
Good Manufacturing Practices (GMPs)
Certification
Corrective and Preventive Action - Vital Quality Principles to Drive a Proper CAPA
Timeline
Senior Manufacturing Supervisor
Ethicon
07.2022 - Current
Senior Quality Assurance Engineer
Flextronics Ltd
07.2021 - 07.2022
J&J Green Belt Course Certified
10-2019
Principal Quality Engineering Technician
Ethicon Inc. - QA Engineering Department
01.2019 - 06.2019
Root Cause Analysis - Root Cause Analysis to Fully Understand the Why Behind a Problem
03-2018
Corrective and Preventive Action - Vital Quality Principles to Drive a Proper CAPA
06-2017
Senior Quality Engineering Technician
Ethicon Inc. - QS Department
05.2017 - 12.2018
Process Excellence Technician
Biosense Webster - PEDepartment
10.2016 - 05.2017
Customer Logistics & Planning (CLP) Co-Op Associate
BOSCH Group - CLPDepartment
09.2015 - 08.2016
PCSL Assistant Coordinator
Bishop's University - CSLDepartment
04.2013 - 05.2014
Associate of Science -
Bishop's University
04.2013 - 2014.05
Bachelor of Science -
Universidad Autónoma De Ciudad Juárez
08.2011 - 2016.05
Quality Engineering Engineer
Ethicon Inc. - QA Engineering Department
6 2019 - 06.2021
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