Summary
Overview
Work History
Education
Skills
Languages
Timeline
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Jessica Gonzalez-Galindo

Portage,IN

Summary

Results-oriented engineering professional with 15 years’ experience and expertise in all aspects of assembly, testing and document control for a Fortune 500 industrial manufacturer. Adept at hands-on assembly as well as testing of electrical and mechanical products. Skilled in collaborating with all members of an organization as well as external organizations to gain consensus and ensure compliance with Good Documentation Practice (GDP) and Good Manufacturing Practice (GMP) in the review of Batch Production Records / Device History Record (BPR/DHR). Produce ISO compliant labeling documents. Diligent Senior Technical Writer with solid background in creating comprehensive technical documentation. Proven ability to streamline complex information into user-friendly guides, enhancing product usability and customer satisfaction. Demonstrated expertise in documentation management and software tools, ensuring high standards of accuracy and clarity. Developed comprehensive writing and editing skills in fast-paced, technology-driven environment. Demonstrated expertise in creating detailed manuals and user guides while collaborating with cross-functional teams. Seeking to transition into new field to leverage these transferable skills and contribute to innovative projects.

Overview

18
18
years of professional experience

Work History

Senior Technical Writer

CYNOSURE, LLC.
02.2022 - Current
  • Collaborate with Engineering and Clinical department to write, edit and design technical documentation
  • Mentored junior technical writers, providing guidance on best practices and fostering professional development within the team.
  • Supported sales teams with tailored documentation to demonstrate product capabilities during client presentations, leading to increased business opportunities.
  • Enhanced documentation quality by implementing standardized templates and style guides for all technical materials.
  • Received recognition from company leadership for excellence in delivering high-quality documentation under tight deadlines.
  • Managed version control and timely updates of documents through effective project tracking and organization skills.
  • Conducted thorough document reviews to identify inaccuracies, inconsistencies, or areas needing clarification.
  • Collaborated with cross-functional teams to gather information for accurate and comprehensive documentation.
  • Edited and proofread technical documents for accuracy and consistency.
  • Coordinated with subject matter experts to ensure the accuracy of technical content in documentation projects.
  • Worked closely with software engineers, product managers and other departments to determine accuracy and completeness of technical documentation.
  • Write, edit, extract and design technical documentation such as operator manuals, treatment guides, and clinical information in multi-page MS Word format, Adobe Illustrator, Photoshop and InDesign including a variety of data tables, graphics, charts, borders, and fonts
  • Create and maintain product device labels and IFUs
  • Create, review, and update labels for compliance of products for submission (Canada, EU, and APAC) per required standards
  • Review changes to applicable standards
  • Develop print specifications for documents
  • Support translation activities such as working with vendors for printing and translating documents
  • Draw/create and/or select graphic charts, working drawings, illustrations, etc., for operator’s manuals or similar projects; adapt sketches/drawings to meet specific technical and publication requirements
  • Write ECOs, create Bills of Material and documents
  • Review and approve physical proofs of translations, IFUs, treatment guides, etc
  • A company that develops and manufactures light-based aesthetic and medical treatment systems for hair removal, skin revitalization, scar reduction, gynecological health, and body contouring

Quality Associate/Consultant

AQUESTIVE THERAPEUTICS
04.2021 - 07.2022
  • Analyzed complex data sets to identify trends and inform decision-making processes
  • Performed routine equipment calibrations, ensuring accurate measurements were obtained consistently throughout testing processes.
  • Actively participated in cross-functional problem-solving sessions, leveraging expertise in quality principles as well as strong analytical skills.
  • Participated in internal audits to identify areas for improvement and ensure adherence to established procedures.
  • Implemented risk management strategies to mitigate potential threats to project success
  • Reviewed documentation for accuracy and compliance, ensuring adherence to organizational standards
  • Enhanced operational efficiencies by leading process improvement initiatives across various departments
  • Ensured regulatory compliance by monitoring and updating policies in line with industry standards
  • A pharmaceutical company that offers medicines and therapeutic solutions, as well as engages in late-stage proprietary product pipelines for the treatment of central nervous system diseases
  • Examined products for imperfections and defects.
  • Followed safety protocols while handling hazardous materials.
  • Provided feedback to production team regarding product quality.
  • Weighed products prior to shipment to confirm accuracy.
  • Followed standard operating procedures for inspections and tests.

QC Coordinator

PAKET CORPORATION
04.2020 - 03.2021
  • Facilitated team collaboration by promoting open communication and sharing best practices among members
  • Established and tracked quality department goals and objectives.
  • Monitored staff organization and suggested improvements to daily functionality.
  • Inspected products and worker progress throughout production.
  • Reported production malfunctions to managers and production supervisors.
  • Led a team of QC technicians in executing daily tasks diligently while upholding core values such as attention-to-detail and commitment toward excellence.
  • Analyzed complex data sets to inform decision-making and improve overall outcomes
  • Implemented process improvements that enhanced efficiency and effectiveness in service delivery
  • Ensured compliance with established standards by regularly reviewing and updating policies and procedures
  • Oversaw quality assurance processes to maintain high standards of service and patient care
  • Coordinated training programs for staff to enhance skills and promote professional development
  • A full turnkey manufacturing facility for R&D/new product development, compounding, filling, sealing and secondary packaging services for health & beauty, OTC, household & cleaning, industrial and healthcare industries

Quality Engineer / Document Control

PARKER HANNIFIN CORPORATION
01.2010 - 01.2019
  • Supported manufacturing / quality documentation control audits resulting in meeting regulatory compliance standards
  • Created, processed, and released Bill of Materials (BOM) for medical products and Purchase Orders (POs) to buy raw material for production
  • Generated Non-Conformance Material Reports (NCMRs), Corrective Action Preventive Actions (CAPAs), Discrepancy Reports (DRs), Manufacturing Procedures (MPs), and protocols
  • Trained and supervised Quality Inspectors in performing mechanical and quality inspections on assembled medical devices to ensure the highest quality of products were assembled
  • A medical device contract manufacturer for the assembly, testing, packaging made of ultra-precision, devices including plastics, metals, and UV curable materials (Class I, II, III)
  • Designed and implemented quality control processes to facilitate customer satisfaction.
  • Contributed to root cause analysis to determine core reason for failures and errors.
  • Performed quality inspections and drafted reports to detail non-conforming material issues.
  • Collaborated with external auditors during annual reviews, ensuring a seamless audit process with minimal findings or discrepancies noted.
  • Verified construction documentation to meet client requirements and vision.
  • Collaborated with other departments to facilitate successful project completion.

Manufacturing Assembler / Labeling Specialist / Document Control

PARKER HANNIFIN CORPORATION
01.2007 - 01.2019
  • Assembled and tested products in a Class 7 (Class 10,000) cleanroom for medical device product line
  • Actively participated in cross-functional team meetings for problem-solving discussions around product designs or manufacturing challenges.
  • Minimized downtime during shift changes through efficient handoff procedures and clear communication with incoming teams.
  • Collaborated with team members to ensure timely completion of orders and meet production goals.
  • Tested products or subassemblies for functionality or quality and troubleshot problems with equipment, devices, or products.
  • Calibrated machines to maintain required productivity levels and adherence to quality standards.
  • Assembled parts correctly according to specifications, reducing quality issues.
  • Coordinated with other departments to complete projects within deadline.
  • Inspected completed products to encourage quality and adherence to company standards.
  • Trained new assembly personnel on proper use of equipment.
  • Utilized blueprints, schematics and diagrams to accurately complete tasks.
  • Assisted in development of new assembly processes.
  • Demonstrated flexibility in adapting to different roles within the manufacturing process as needed based on workload fluctuations or skill requirements.
  • Increased team output by cross-training in multiple assembly areas when needed.
  • Promoted to labeling specialist after acquiring requisite knowledge required to effectively design FDA approved labels
  • Collaborated cross-functionally to design, process, validate, and release product labeling including UDI barcode generation and control in compliance with FDA regulations
  • Printed and issued labels for medical devices
  • A medical device contract manufacturer for the assembly, testing, packaging made of ultra-precision, devices including plastics, metals, and UV curable materials (Class I, II, III)

Education

Master of Information Technology -

Southern New Hampshire University
Manchester, New Hampshire

Master of Arts - Special Education and Digital Technology

Azusa Pacific University
Azusa, CA

Bachelor of Arts - Liberal Studies and Spanish

California State University
Chico, CA

Skills

  • Quality Audits
  • Product Assembly
  • Testing
  • Strategic Planning
  • Analysis
  • Quality Inspections
  • Bill of Materials
  • Purchase Orders
  • Production Line Development
  • Label Design
  • Control
  • Training
  • Development
  • MS Office Suite
  • AutoCAD
  • Solidworks
  • EasyLabel
  • Codesoft
  • Bradyman
  • Labelview
  • Label Matrix
  • Bartender Barcode Software
  • Adobe Illustrator
  • InDesign
  • Photoshop
  • SAP Software Solutions
  • ISO 9000
  • FDA
  • GDP
  • GMP
  • ISO 13485
  • 21CFR
  • 21CFR211
  • Peer Review Coordination
  • Advanced Technical Knowledge
  • Strong Research Abilities
  • Information Architecture Design
  • Localization and Translation
  • API Documentation Proficiency
  • Technical Editing Competence
  • Editing and proofreading
  • Microsoft Publisher
  • Organizational Skills
  • Team Collaboration
  • Multitasking Abilities
  • Reliability
  • Analytical Thinking
  • Problem-Solving

Languages

Spanish
Native or Bilingual

Timeline

Senior Technical Writer

CYNOSURE, LLC.
02.2022 - Current

Quality Associate/Consultant

AQUESTIVE THERAPEUTICS
04.2021 - 07.2022

QC Coordinator

PAKET CORPORATION
04.2020 - 03.2021

Quality Engineer / Document Control

PARKER HANNIFIN CORPORATION
01.2010 - 01.2019

Manufacturing Assembler / Labeling Specialist / Document Control

PARKER HANNIFIN CORPORATION
01.2007 - 01.2019

Master of Arts - Special Education and Digital Technology

Azusa Pacific University

Bachelor of Arts - Liberal Studies and Spanish

California State University

Master of Information Technology -

Southern New Hampshire University

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Jessica Gonzalez-Galindo