PILAR GONZALEZ

Quality Engineer

Email

ad1t05@r.postjobfree.com

Phone

207-***-****

Skills

Corrective and Preventive Action (CAPA) Environmental Monitoring Good Documentation Practice (GDP) Good Manufacturing Practice (GMP) Medical Devices Product Design Quality System Risk Management Root Cause Analysis SAP ENSURE Validation Engineer Process Engineer Manufacturing Engineer

Professional Experience

Mar 2021 - Sep 2023

Manufacturing Line Quality Engineer / Team Lead, Abbott Laboratories

Scarborough, ME

Supported Production on the manufacturing floor and Material Handling in the warehouse.

Evaluated data to monitor production’s performance in relation to quality.

Assessed severity of risks of quality incidents observed on the manufacturing floor.

Identified root causes of production problems.

Recommended resolutions of identified deviations from established product or process standards.

Led daily Quality and Production meetings covering identified quality incidents and covered knowledge gap training.

As team lead, trained existing team members and performed team’s new hire training.

Educated and trained production personnel on continual quality improvement changes applied to the documentation of batch record recording.

Participated in internal or external training programs to maintain knowledge of engineering principles, industry trends, or novel technologies.

Conducted validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.

Analyzed validation test data to determine whether systems or processes met validation criteria.

Conducted audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.

Prepared, maintained, or reviewed validation and compliance documentation, such as engineering change notices, schematics, or protocols.

Ensured adherence to procedures and verified documentation to ensure compliance with FDA and ISO standards.

Identified variations between manufacturing processes, batch records, and SOPs.

Helped with Impact Assessments using Agile, SQL Server Reporting Services, and pMFEAs.

Acted as Initiator of Quality Incidents using Agile, and communicated with cross-functional departments.

Conducted periodic Quality Assurance Audits.

Aug 2018 - May 2019

Biomedical Engineer, UT Dallas

Richardson, TX

Adapted and designed computer hardware or software for medical science applications.

Conducted training sessions to educate clinicians and other personnel on proper use of equipment.

Authored documents outlining protocols, policies, and standards for the use, maintenance, and repair of medical equipment.

Designed and conducted follow-up experiments based on generated data to meet established process objectives.

Developed medical diagnostic or clinical instrumentation, equipment, or procedures using engineering and biobehavioral science principles.

Directed bench or pilot production experiments to optimize product yield and minimize production costs.

Developed methodologies for transferring procedures or biological processes from laboratories to commercial-scale manufacturing production.

Managed a team of engineers, overseeing schedules, inventory, budgets, and contract obligations.

Prepared project plans for equipment or facility improvements, including timelines, budgetary estimates, and capital spending requests.

Stayed abreast of scientific, industrial, or technological advances by reading current scientific or trade literature.

Recommended process formulas, instrumentation, or equipment specifications based on results of bench or pilot experimentation.

Reviewed existing manufacturing processes to find opportunities for yield improvement or reduced process variation.

Aug 2017 - Aug 2018

Quality Control Chemist, Chem-Aqua and Certified Laboratories Divisions of NCH Corporation

Irving, TX

Performed quality assurance testing assessing products based on regulatory metrics.

Resolved quality issues in accordance to established procedures.

Documented batch identification numbers, test results, and methods to correct batches.

Labeled and stored samples for each batch manufactured.

Monitored aging of each product.

Assessed reported issues via testing.

Implemented good laboratory practice (GLP) to assure consistent quality and integrity for regulated products.

Manufactured to ISO 9001 and ASTM Standards and government regulations.

Induced changes in composition of substances by introducing heat, light, energy, or chemical catalysts for quantitative or qualitative analysis.

Studied effects of various methods of processing, preserving, or packaging on composition or properties of foods.

Prepared test solutions, compounds, or reagents for laboratory personnel to conduct tests.

Evaluated laboratory safety procedures to ensure compliance with standards or to make improvements as needed.

Compiled and analyzed test information to determine process or equipment operating efficiency or to diagnose malfunctions.

Maintained laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed.

Jul 2014 - Mar 2021

Lead Brand Representative, High Profile Promotions, Inc.

Dallas, TX

Promoted to event lead in only 3 months managing events and staff of +5 members

Worked at 5 different global marketing agencies for clients (IBM, Nike, P&G, AT&T, etc.) while getting my engineering degree

Responsible for onsite training, writing event & finance reports

Education

Aug 2008 - May 2012

Associate's Degree, Art/Art Studies, General.

Tarrant County Community College, Fort Worth, TX

Aug 2015 - May 2019

Bachelor's Degree, Bioengineering and Biomedical Engineering.

University of Texas at Dallas, Richardson, TX

Awards

Honor Society Scholarship

Recipient of Phi Theta Kappa Honor Society Scholarship.

Contact this candidate