Estelle Kamwa - Document Management / Document Controlling Specialist

Q: Where is Estelle based?

Estelle is based in Stade, Germany and can operate in on-site , hybrid , and remote work models.

Q: What languages does Estelle speak?

Estelle speaks the following languages: German (Advanced), English (Advanced), Spanish (Advanced), French (Advanced) .

Q: What is Estelle's latest experience?

Estelle's most recent position is Document Management / Document Controlling Specialist .

Q: What is Estelle's education?

Estelle holds a Bachelor in Mechanical Engineering .

Q: Does Estelle have any certificates?

Estelle has 43 certificates . Among them, these include: AI For Translators – Editions I & II , Basics Of AI & Prompting For Translators And Interpreters , and Best Practices Dictating With Dragon .

Q: What is the availability of Estelle?

Estelle is immediately available full-time for suitable projects.

Q: How to hire Estelle?

To hire Estelle, click the Meet button on the profile to request a meeting and discuss your project needs.

Recommended expert

Stade, Germany

Experience

Document Management / Document Controlling Specialist

Implement version control, approval workflows, document traceability across departments and project phases; align with ISO 9001 and MDR requirements
Maintain documentation audit trails; coordinate revision cycles with engineering, QA, regulatory teams; support internal audits and CAPA reviews
Coordinate preparation, validation, archiving of multilingual technical files and regulatory submissions (English, German, French)
Facilitate project handover: track engineering changes, align documentation milestones, compile client/regulatory packages
Enforce confidentiality and data integrity: ensure GDPR compliance, secure archiving, produce document status reports and metadata analytics

LLM-Evaluation & Prompt Engineering Specialist

Design of evaluation criteria: define quality dimensions (accuracy, relevance, completeness, tone, style, safety); create scoring rubrics, reference completions
Creation and management of test sets: develop prompt libraries (normal, edge, adversarial); maintain version control, documentation for testing reproducibility
Manual evaluation of responses: review and score LLM outputs; detect and log hallucinations, bias, errors, safety risks
Calibration and auditing: train evaluators, monitor inter-annotator agreement; implement QA controls for annotation consistency
Metrics tracking and reporting: monitor KPIs (win rate, error rate, factual accuracy, harmlessness, helpfulness); produce performance reports with improvement suggestions
Feedback for model improvement: deliver structured feedback to engineering and research teams; support prompt optimization, model fine-tuning
Safety and compliance: identify toxic, biased, non-compliant content; propose guardrails, ethical moderation strategies

Product Development, Requirements & Systems Engineer

Implement system lifecycle models per ISO/IEC 15288 and German V-Modell from concept to retirement for medical devices
Define functional and technical architectures: create system block diagrams, interface control documents for embedded electromechanical systems
Ensure design input/output traceability: link stakeholder requirements, design outputs, risk mitigations, verification evidence (e.g., infusion pump development)
Coordinate cross-functional teams (engineering, QA, usability, regulatory) to integrate risk controls and usability features
Manage change and configuration: maintain version-controlled workflows, impact analysis for Class IIb diagnostic platforms
Decompose user needs into system-level requirements with full traceability; lead requirements engineering for rehabilitation robotics

Project Manager

Project planning and scheduling: develop Gantt diagrams, WBS, critical path analysis with Primavera P6, MS Project
Milestone tracking: define phases, deliverables, approval gates to control timelines; align cross-functional workflows
Budget and resource allocation: monitor labor distribution, vendors, CAPEX/OPEX forecasting
Integrate regulatory compliance planning: embed ISO 13485, MDR, RoHS/REACH/CE requirements with internal QA checkpoints
Risk identification and mitigation: create risk registers, scoring matrices, contingency plans; collaborate with technical and quality teams
Stakeholder engagement and reporting: produce multilingual status reports, dashboards, weekly KPI summaries

Regulatory Affairs Consultant & Quality Manager

Preparation and translation of technical files: Design History Files (DHF), Risk Management Files (RMF), GSPR checklists, Summaries of Safety and Clinical Performance (SSCPs), Clinical Evaluation Reports (CERs)
Drafting Post-Market Surveillance (PMS) Plans, Periodic Safety Update Reports (PSURs), Post-Market Clinical Follow-Up (PMCF) documentation per MDR 2017/745
Implementation of ISO 13485 QMS: develop SOPs, risk assessment tools, audit documentation; integrate CAPA processes
Oversight of UDI systems, device labeling, multilingual IFUs in line with RoHS, REACH, IEC 62366; ensure EMC compliance (IEC 60601), Machinery Directive 2006/42/EC
Translation and coordination of multilingual regulatory submissions for notified bodies and authorities

SAP Consultant

Integrate SAP MM, SD, QM, PP modules: configure transactional workflows, reporting, inter-module coordination
Implement master data governance: control materials master, BOMs, vendor and customer data for operational efficiency and audit readiness
Map and optimize end-to-end processes using LSMW, custom T-codes, Fiori apps
Align SAP workflows with MDR, ISO 13485, RoHS/REACH requirements
Develop multilingual training manuals, test scripts, provide real-time support to SAP end-users

Software-Testing Specialist

Design and execute test cases: create test plans, scripts, checklists based on user stories and requirements
Report and track bugs via Jira, TestRail, Redmine; include screenshots and severity classification
Conduct cross-browser (Chrome, Firefox, Safari) and mobile (Android, iOS) testing
Perform multilingual and linguistic QA: verify string length, truncation, contextual fit
Execute regression testing after patches or UI changes to ensure functionality stability
Check compliance and accessibility per WCAG, ISO/IEC 25010, EU MDR usability criteria

Technical & Medical Translation & Writing Specialist

Translation of complex medical and pharmaceutical documentation, including clinical trial protocols, informed consent forms (ICFs), summaries of product characteristics (SmPCs), patient leaflets, pharmacological monographs, and internal documents for hospitals and pharmaceutical labs
Regulatory writing and technical translation aligned with European and international standards, covering Risk Management Reports, PMS-Plans, CAPA documentation, and Design History Files (DHF); compliance for CE marking, RoHS, REACH, MDR 2017/745, ISO 13485, FDA 21 CFR
Technical translation and editing for industrial, electronics, and medical technology sectors: operating manuals, installation guides, safety instructions, datasheets, validation protocols
Documentation preparation and localization for medical devices in compliance with IEC 62366 (usability) and IEC 60601 (EMC); deliverables include IFUs, SSCPs, device labeling, multilingual design files
Marketing localization, UX writing, and SEO adaptation for digital platforms and e-commerce; product pages, landing pages, e-learning modules, UX flows, onboarding content in English, German, French

Transcription & Subtitling Specialist

Subtitler at SousTitreur.com: deliver accurate, timely subtitles for media agencies and streaming clients
Subtitler for Prostitution Research Conference (Berlin 2022): full multilingual video subtitling (EN/DE/ES) including trauma-sensitive content
Medical Transcriptionist at iMerit: manual and AI-based transcription for healthcare projects (EN ⇄ FR)
Subtitler & Editor at ElevenLabs: improve AI-generated subtitles for clarity and natural flow
Subtitler at Infohana: institutional and corporate video subtitling, time-coded captions, quality control

Languages

German

Advanced

English

Advanced

Spanish

Advanced

French

Advanced

Education

Bachelor's degree, Air-Conditioning, Refrigeration, and Environmental Technology · Mechanical Engineering

Certifications & licenses

AI For Translators – Editions I & II

Basics Of AI & Prompting For Translators And Interpreters

Best Practices Dictating With Dragon

CE Marking & Risk Management For Medical Devices

TÜV Rheinland

CE Marking For Medical Devices

TÜV Rheinland

Change & Configuration Control In Regulated Environments

Internal QA-Workshop

ChatGPT And Bard For Translators

Clinical Trials Explained For Translators (Ed. I & II)

Design & Development Of Medical Devices

TÜV Rheinland

Document Control For Engineering & Construction Projects

Internal Training

Documentation & Engineering Project Experience

EIKO-Anlagenbau- & -Prüfungsgesellschaft MbH

E-Mail-Marketing & Copywriting For Language Professionals

Functional Specifications & Traceability Management

In-house program, Device Master

Fundamentals Of Medicine For Translators

Guide To Translating User Manuals

GxP & SAP Compliance In Regulated Industries

How To Create Error-Free Subtitles

ISO 9001 Quality Management Principles

Introduction To Medical Device Localization

MS Project Training – Microsoft Project Fundamentals & Advanced Online Course

Machinery Directive 2006/42/EC

WEKA-Akademie

Marketing Translation For Pharma Companies

Material Master Data Strategy In SAP

Pharmacology For Translators & Interpreters (Ed. I & II)

Post-Market Surveillance & CAPA

TÜV Rheinland

Post-Market Surveillance & CAPA In MDR

TÜV Rheinland

Primavera P6 Project Management Training

Internal Program / Online Certification

Product Development & Systems Engineering

Internal Program (aligned with INCOSE / ISO/IEC 15288)

Prompt Engineering Tools & Apps For Translators

Regulatory Writing And Documentation In Pharma

Private Modules

Requirements Engineering

IREB / INCOSE Foundations

SAP ERP Fundamentals

SAP Quality Management Processes (QM)

Subtitling: A Comprehensive Course

Technical Documentation For Medical Devices

TÜV Rheinland

Technical Translation And Documentation

Technical Writing: How To Write Software Documentation

The Complete 2025 Software Testing Bootcamp

The Ultimate SAP S/4HANA Course 2025: From Zero To Expert

Transcreation Masterclass (III Ed. 2025)

Typing Test – 33 WPM, 96% Accuracy

Typing.com

Verified Medical Transcription Experience

iMerit Inc.

Writing For Localization & UX Content

Statistics

Experience

Total positions 9

Qualifications

Highest degree Bachelor

Certifications earned 43

Profile

Created

October 2025

Last Update

January 2026

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Estelle based?

Estelle is based in Stade, Germany and can operate in on-site, hybrid, and remote work models.

What languages does Estelle speak?

Estelle speaks the following languages: German (Advanced), English (Advanced), Spanish (Advanced), French (Advanced).

What roles would Estelle be best suited for?

Based on recent experience, Estelle would be well-suited for roles such as: Document Management / Document Controlling Specialist, LLM-Evaluation & Prompt Engineering Specialist, Product Development, Requirements & Systems Engineer.

What is Estelle's latest experience?

Estelle's most recent position is Document Management / Document Controlling Specialist.

What is Estelle's education?

Estelle holds a Bachelor in Mechanical Engineering.

Does Estelle have any certificates?

Estelle has 43 certificates. Among them, these include: AI For Translators – Editions I & II, Basics Of AI & Prompting For Translators And Interpreters, and Best Practices Dictating With Dragon.

What is the availability of Estelle?

Estelle is immediately available full-time for suitable projects.

What is the rate of Estelle?

Estelle's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.