Technical Writer Senior

Luis R. Gámez

**** **** ***** ****, ****** OH ***10-3221 · 269-***-****

Email: *******.****@*****.*** · LinkedIn: luis-gamez-2516238 · Skype: salseroluis

Seeks full-time position (remote or hybrid) as ISO Documentation Manager or Senior Technical Writer for Quality and Compliance in a fast-paced high-tech regulated enterprise

Core Skills

20 years QMS Technical Writer in regulated industries: ISO 9001 / AS 9100 / ISO 13485 / CFR Part 820 / HIPAA / Sarbanes-Oxley / CMMC

Exceptional analytical / presentational skill with cross-functional teams; training & development

QA Engineering support: medical devices, molding, metal fabrication, robotic welding, SQL database design, automated Quality checks

20+ years writing, editing, revision management, document control admin

Cybersecurity reporting, Corrective / preventative actions, lead Internal Auditor

Expert MS Office (Excel, Word, PowerPoint, Visio); mastery Slack, Confluence, Qualio, Jira

Superior communication, team-building, and interpersonal skills

Experience

OCT 2024 – MAR 2025

Program / Project Manager, Amazon Robotics (Contract)

Sr. Technical Writer and analyst, Mechatronics & Sustainable Packaging-CX Deployability team

Work Instructions and Time Studies to maximize cycle-time efficiency in Robotic deployments

MAY 2022 – AUG 2024

Senior Technical Writer, Information Security (Digital Technology), Ginkgo Bioworks

Administrator for Security and Compliance Documented Information; QMS system administrator

Author Cyber Threat Intelligence Report; Cyber Threat Incident Reporting

User-facing and SOX-compliance documentation for new software launch

Business Continuity / Data Recovery; SOX, HIPAA, CMMC policies, QMS compliance document stack

FEB 2018 – APR 2022

Quality Systems Specialist, Gemcity Engineering & Manufacturing (dba Libra Industries)

Quality Management Systems (QMS) Documentation Administrator; Senior Technical Writer

QMS documentation, Management Review reporting; Corrective Actions Process Owner

Lead Internal Auditor / Trainer (certified AS9100D, ISO 13485:2016, ISO 9001:2015)

JUN 2017 – OCT 2017

Quality Systems Technical Writer, Zimmer Biomet (Contract)

Technical Writer in Engineering for Change Management system update

FDA 483 / CAPA process remediation work streams

Shared Documentation Services: Drafted Environmental Health & Safety document cascades for ISO 14001 and ISO 45001 certification audits.

JUL 2016 – OCT 2016

Supplier Quality Engineer, Aspen Surgical / Hill-Rom (Contract)

Supplier Quality team in global surgical device manufacturer

MRB (raw material review) and Supplier issues: NCE case, Scars, Engineering change

Incoming Inspection team leader; QA/RA, Receiving / Inventory / Material Handling teams

DPPM Quality trending analysis; Supplier Quality trends, Dock metrics

FEB 2015 – JUL 2016

Quality Engineer, Douglas Autotech Corporation

Quality Engineering support (robotic welding, metal fabrication, final assembly)

Technical Writer: CAPA documents, monthly quality reports, TS 16949 QMS documentation

Monitor containment & corrective actions; monitor supplier defects; PPAP submission

JUN 2010 – OCT 2014

Technical Writer / Advanced R&D Engineering, CTS Corporation

Technical writer: QS procedures, Operation manuals, Work Instruction

Design / maintain procedures for product development / PLM system

Advanced Quality systems: control plans, PPAP / Production Release; CAPA; Validation testing

SQL Database design: online quality checks database for actuator assembly line

Mfg. support: injection molding, sensor final assembly, actuator final assembly

JAN 2012 – JUN 2012

Quality Systems Technical Writer, Mann+Hummel Usa, Inc. (Contract)

Quality Systems procedures, instructions for multi-national business unit

Compliance TS 16949 standards; Problem-solving specialist: A3, Drill Deep, 8-D, 5-Why

SEP 2008 – SEP 2010

Technical Writer, Explainers / The Bishop Company (Contract)

Contract technical documentation, desktop publishing

Writing / editing / publishing manufacturing work instructions

MAY 2006 – MAY 2008

Business Communications Faculty, University of Phoenix (Part-Time)

Business writing / Humanities instructor, College of Arts and Sciences

Curricula development; PowerPoint training; remote instruction of non-traditional students

FEB 2004 – FEB 2005

Quality Coordinator, Summit Polymers Inc

TS 16949 quality systems specialist; Corrective Action Reports specialist

Document control specialist: APQP, PPAP, PFMEA, SPC, Pareto analysis

AUG 2003 – SEP 2006

Quality Inspector, Product Action International

Third-party Quality Control services, ISO 9002 compliant

Sorting, inspection, containment, rework; Engineering technical support

Education

Bachelor of Arts, University of Notre Dame

English / Chemistry Majors

Notre Dame Scholar

Master of Arts, University of Virginia

English Literature (medieval studies)

The Raven Society (honorary academic society)

Contact this candidate