Hello · Hola

Karla P. Hoffer

Quality Engineer & Technical Support

Bilingual engineer with a medical-device quality career — supplier audits, CAPAs, and process validation under ISO 13485, FDA, and EU MDR — now hands-on with WordPress, WooCommerce, payment gateways, and workflow automation. Root cause, fix, document.

At a Glance

$150K+

Annual supplier
cost savings

95%

Audit compliance
across 50+ audits

10/10

CSAT rating
100+ submissions

65%

Packaging cost
reduction

About

I’m a bilingual engineer who moves comfortably between two worlds. My foundation is regulated medical-device quality engineering — leading supplier audits, CAPAs, and IQ/OQ/PQ process validation under ISO 13485, FDA, and EU MDR at Arthrex, Cook Medical, and Boston Scientific. Before that I spent four years in bioengineering research, designing microfluidic devices and co-authoring six peer-reviewed papers.

Today I bring that same rigor to hands-on web operations: building and supporting WordPress and WooCommerce sites, payment integrations, CRMs, and automation.

“Find the root cause, fix it, document it.”

Details

Experience

Senior Technical Support Engineer

Adroited LLC · Remote (Contract) · Feb 2026 – Jul 2026

Delivered customer support by phone, email, and Zoom under SLA adherence, earning a perfect 10 CSAT rating across 100+ survey submissions.
Built and launched client WordPress websites with Elementor and Gutenberg, and provided ongoing administration: core, theme, and plugin updates, security patching, backups, and user management.
Configured WooCommerce storefronts end to end — product catalogs, Stripe, Square, and PayPal gateways, ShipStation shipping, coupon campaigns, and abandoned-cart recovery with automated email follow-ups.
Set up on-page SEO with Yoast, built lead-capture forms (WPForms, Ninja Forms, Contact Form 7), and performed ADA/WCAG accessibility remediation.
Administered SuiteCRM and GoHighLevel pipelines, authored client onboarding documentation in DokuWiki, managed DocuSeal/SignNow signature workflows, and automated cross-platform data flow with Zapier.

Supplier Quality Engineer

Arthrex · Hybrid · Oct 2023 – Feb 2025

Led supplier performance monitoring of 2,000+ suppliers with risk assessments and quality-metric analysis, improving supplier quality performance 15% through proactive coaching and CAPA execution.
Led a Supplier Selection & Validation Initiative (SSVI) that delivered ~$150K in annual cost savings through on-site audits and IQ/OQ/PQ process-control verification.
Spearheaded development of an internal quality-improvement software to automate QMS processes, reducing manual errors and improving compliance tracking across departments.
Directed supplier NCRs, SCARs, and CAPAs; reviewed Gage R&R and capability-study data against ISO 13485 and ISO 9001 standards.

Manufacturing & Supplier Quality Engineer II

Cook Medical · Bloomington, IN · Mar 2022 – Jun 2023

Served as Lead Quality Representative across multiple medical-device product lines, owning non-conformance investigations, root-cause analysis (RCCA/8D), and CAPA.
Led a nonconformance-reduction project targeting foreign-matter contamination — updated Manufacturing Instructions and QCI procedures, introduced magnification inspection, and revised PFMEA and Hazard Analysis.
Managed supplier containment (SCAR, FAR) for raw-material contamination, coordinating with Regulatory, Medical Affairs, and Engineering.
Investigated a 70%+ defect rate after a process transfer, became SME on process flow, identified 30+ process flaws, and served as interpreter during the on-site supplier audit.

Quality Engineer

Boston Scientific · Oct 2021 – Mar 2022

Supported the LithoVue™ Single-Use Digital Flexible Ureteroscope production line, ensuring regulatory compliance under ISO 13485.
Led a full production-line relocation spanning 300+ inspection and qualification activities with zero unplanned downtime during transfer and validation.
Conducted 10+ internal audits, reducing process deviations by 20%, and cut incoming-part scrap 10% by resolving systemic supplier nonconformities.

Research Assistant

University of Illinois Urbana-Champaign · Jul 2017 – Oct 2021

Designed microchips, microelectrode arrays, microfluidic systems, and PCBs to study 3D tissue and neural-network biology in a multidisciplinary lab.
Co-authored six peer-reviewed papers (Science Advances, PNAS, Scientific Reports, Cancers, Lab on a Chip) and contributed to a pre-patent provisional (Serial #62/293,836).

Toolbox

Two disciplines, one habit: make it work, then make it documented.

Quality & Compliance

ISO 13485 ISO 9001 EU MDR FDA ISO 14971 ISO 19011 Supplier Quality Lean Manufacturing

Auditing & Validation

Certified Lead Auditor RCCA CAPA 8D 5-Why PPAP FAI IQ / OQ / PQ PFMEA SCAR / FAR NCR

Data & Enterprise

Six Sigma Gage R&R Process Capability Minitab Power BI SAP Windchill Documentum PLM GD&T

Web & CMS

WordPress Elementor Gutenberg WooCommerce WPForms Ninja Forms Contact Form 7 Yoast SEO ADA / WCAG

Payments & Integrations

Stripe Square PayPal Zapier ShipStation DocuSeal SignNow

CRM & Support

SuiteCRM GoHighLevel Zoom VoIP SLA Management Escalations DokuWiki

Publications

Three-dimensional microscale hanging drop arrays with geometric control for drug screening and live tissue imaging

Science Advances · 2021

Modulating electrophysiology of motor neural networks via optogenetic stimulation during neurogenesis and synaptogenesis

Scientific Reports · 2020

Engineering geometrical 3-dimensional untethered in vitro neural tissue mimic

PNAS · 2019

Mesenchymal Cells Support the Oncogenicity and Therapeutic Response of the Hedgehog Pathway in Triple-Negative Breast Cancer

Cancers · 2019

Razor-printed sticker microdevices for cell-based applications

Lab on a Chip · 2018

Open multi-culture platform for simple and flexible study of multi-cell type interactions

Lab on a Chip · 2018

Education

M.S. Bioengineering

University of Illinois, Urbana-Champaign · May 2021 · GPA 3.49

B.S. Chemical Engineering

University of Puerto Rico, Mayagüez · December 2016 · GPA 3.56

English — native / bilingual Español — native / bilingual

Recognition

$150K+ annual cost savings from a supplier selection & validation initiative, with 50% on-time-delivery improvement.
15% supplier defect-rate reduction through coaching, CAPA execution, and continuous-improvement plans.
95% audit compliance across 50+ supplier audits (ISO 13485, FDA, EU MDR).
Perfect 10 CSAT rating across 100+ customer-support surveys.
Pre-patent provisional application, Serial #62/293,836.

Let’s connect.

Interested in working together? Reach out any time — in English or Spanish.

Karla P. Hoffer

Florida
(239) 677-5467
Karla@srcode.com
English & Spanish — bilingual

Objective

Tech-comfortable bi-lingual operator who enjoys keeping systems running and helping people get unstuck. Hands-on with WordPress, Elementor, WooCommerce, payment gateways, and workflow automation, with direct experience supporting customers by email and phone and building documentation that reduces repeat questions. A quality engineering background brings a calm, logical approach to closing the loop — find the root cause, fix it, document it.

Education

University of Illinois, Urbana-Champaign, IL May 2021

Master of Science, Bioengineering — GPA 3.49

University of Puerto Rico – Mayagüez December 2016

Bachelor of Science, Chemical Engineering — GPA 3.56

Key Achievements

$150K+ Annual Cost Savings: Led Supplier Selection & Validation Initiative optimizing Quality Plans, PPAP, Special Process Validation, Gage R&R, Capability Studies, and FAI, achieving 50% OTD improvement.
15% Supplier Quality Improvement: Reduced supplier defect rate by 15% through proactive coaching, CAPA execution, and supplier-driven continuous improvement plans aligned with ISO 13485.
95% Audit Compliance: Conducted 50+ supplier audits ensuring conformance with ISO 13485 and FDA and/or EU MDR standards.
20% Faster NCR Closure: Streamlined deviation and NCR closure workflow, cutting average response time by 20% and improving traceability and corrective-action effectiveness.
Continuous Improvement Leadership: Designed and delivered supplier quality training on RCCA/8D, PPAP readiness, and risk mitigation, elevating team audit performance and supplier engagement.

Technical Skills

Web Development & CMS: WordPress (Elementor, Gutenberg), WooCommerce, WPForms, Ninja Forms, Contact Form 7, Yoast SEO, ADA/WCAG Accessibility Remediation

CRM & Customer Support: SuiteCRM, GoHighLevel, Zoom, SLA Adherence & Escalation Management

Integrations & Payments: Zapier, Stripe, Square, PayPal, ShipStation, DocuSeal, SignNow

Documentation & Software: DokuWiki, Microsoft Office Suite, Adobe Illustrator, AutoCAD, MatLab, Aspen, GAGEtrak

Quality & Compliance: ISO 13485, FDA, ISO 9001, EU MDR, Supplier Quality Management, Lean Manufacturing

Auditing, CAPA & Process Validation: Lead Auditor, RCCA, CAPA, 8D, 5-Why, NCR Resolution, PPAP, FAI, IQ, OQ, PQ, Risk-Based Supplier Audit

Data & Enterprise Systems: Six Sigma, Gage R&R, Capability Studies, Power BI, Minitab, GD&T, PLM, SAP, Windchill, Complaints (SAS), JBase

Experience

Senior Technical Support Engineer | Adroited LLC — Remote (Contract) Feb 2026 – Jul 2026

Delivered amazing customer service under SLA adherence — answering promptly, showing empathy, and resolving complex issues — garnering a perfect 10 CSAT rating across 100+ submissions.
Built and launched WordPress sites (Elementor, Gutenberg) and provided ongoing administration: core/theme/plugin updates, security patching, backups, and user-role management.
Configured WooCommerce storefronts end to end — product catalogs, Stripe/Square/PayPal gateways, ShipStation shipping, coupon campaigns, and abandoned-cart recovery with automated email follow-up.
Set up Yoast SEO, built lead/contact forms (WPForms, Ninja Forms, Contact Form 7), and performed ADA/WCAG accessibility remediation.
Administered SuiteCRM and GoHighLevel pipelines, authored onboarding docs in DokuWiki, managed DocuSeal/SignNow signature workflows, and automated cross-platform data flow with Zapier.

Supplier Quality Engineer | Arthrex — Hybrid Oct 2023 – Feb 2025

Led supplier performance monitoring of 2,000+ suppliers, risk assessments, and quality-metric analysis, ensuring continuous compliance and improvement.
Implemented supplier quality plans, PPAP reviews, and risk-mitigation strategies aligned with ISO 13485; managed Supplier Quality Agreements (SQA).
Directed supplier NCRs, SCARs, and CAPAs using Six Sigma and 8D; executed supplier audits ensuring ISO 13485, FDA, and EU MDR compliance.
Partnered cross-functionally with Sourcing and Engineering to resolve quality barriers and improve delivery performance.

Manufacturing & Supplier Quality Engineer II | Cook Medical — On-Site Mar 2022 – Jun 2023

Lead Quality Representative across product lines, driving CAPA and RCCA/8D initiatives that eliminated recurring quality issues.
Resolved critical packaging nonconformances by qualifying an alternative material — cutting defect rate 30% and packaging cost 65% through supplier collaboration and revalidation.
Directed SCAR, FAR, and IQ/OQ/PQ validation programs, achieving a 25% reduction in total nonconformances.
Led an on-site audit at one of Mexico’s largest component suppliers, identifying 35+ compliance issues and driving corrective actions through retraining and process improvement.

Quality Engineer | Boston Scientific — On-Site Oct 2021 – Mar 2022

Ensured regulatory and quality compliance for single-use ureteroscope production under ISO 13485.
Led a 300+ activity production-line relocation with zero unplanned downtime; performed 10+ internal audits reducing process deviations 20% and incoming-part scrap 10%.

Research Assistant | University of Illinois — On-Site Jul 2017 – Oct 2021

Designed biohybrid neural tissue models; published 6+ peer-reviewed papers advancing 3D tissue engineering, microdevice design, and bio/chem assay methods relevant to diagnostic evaluation.
Applied statistical design and validation methods transferable to manufacturing process control. Pre-patent provisional Serial #62/293,836 (2015).