You're seeing this page as if you were . The main menu is still yours, though. Exit from immersion

About Lili

I help companies in regulated environments keep their quality and documentation processes accurate, compliant, and audit-ready.

With hands-on experience in the medical devices industry, I support organizations working with ISO 13485, GMP, MDR and ISO 9001 standards. I understand how critical it is to maintain high-quality documentation and structured processes — not just for compliance, but for smooth day-to-day operations.

I bring a unique combination of quality assurance, administrative expertise, and operational support. This allows me to work both on detailed QA tasks and broader process improvements.

How I can support you:

Preparing, reviewing, and organizing audit-ready documentation (e.g. Device History Records, supplier files)
Supporting internal audits and maintaining quality systems
Managing non-conformities (NCMR) and CAPA processes
Performing data checks, label inspections, and quality control support
Structuring and improving administrative and operational workflows
Maintaining training records and compliance documentation

I am known for my strong attention to detail, reliability, and structured way of working. I take ownership of my tasks and ensure deadlines are met without compromising quality.

Whether you need ongoing QA support, help preparing for an audit, or reliable backoffice support with a compliance mindset — I can step in quickly and add value.

I am flexible, easy to work with, and comfortable in international, English-speaking environments.
  • English

    Native or bilingual

  • Dutch

    Fluent

Can work on-site
Amersfoort (up to 50km)

Experience

  • Humain Mosaic Human Centered AI
    Co-founder and operational manager
    CONSULTING AND AUDITS
    January 2025 - Today (1 year and 5 months)
    Amersfoort, Netherlands
    • ● Led day-to-day operations and strategic planning, ensuring alignment with the company's mission of promoting inclusive storytelling and human-centered digital engagement.
    • ● Oversaw project execution from concept to delivery, managing timelines, budgets, and partnerships to support impactful content and service development.
    • ● Designed and implemented operational workflows, streamlining internal processes and improving efficiency across creative and administrative functions.
    • ● Built and nurtured relationships with clients, collaborators, and community stakeholders to expand brand presence and generate meaningful impact.
    • ● Coordinated marketing, content creation, and digital outreach strategies, contributing to the brand's voice and visibility across various platforms.
    • ● Conducted market research and user needs analysis to guide service offerings, ensuring alignment with emerging trends in digital culture, social impact, and creative innovation.
    artificial intelligence Team management Business plan Project Management Strategic planning
  • Orbus Neich Medical Company
    Quality Inspector /Quality Assurance Support
    MEDICAL
    January 2021 - January 2024 (3 years)
    Amersfoort, Netherlands
    • ● Products: catheters, stents and Orbital Atherectomy.
    • ● Monitoring QA and QC policies. Based on ISO 13485, ISO 9001 GMP, MDR, Health and Safety rules.
    • ● Coordinate and perform label inspections and receiving inspections.
    • ● After sterilization of the products perform final inspections and release of products.
    • ● Assist in collection of documentation for Interne Audits.
    • ● Issuing NCMR
    • ● Identifying, analyzing, managing non-conformities (NCMR), corrective and preventive actions (CAPA's) from various sources.
    • ● Reviewing and archiving Device History Records, for example: production routers and sterilization certificates.
    • ● Performing Clean room monitoring
    • ● Supporting product biomonitoring
    • ● Performing temperature measurements of anti-bodies
    • ● Update supplier documentation
    • ● Support employee training and maintenance training records.
    • ● Supporting handling and organization of contaminated products and returned products.
    • ● Back up for QA colleague
    • ● Continual improvement Process
    Quality Assurance (QA) ISO 13485 GMP (Good Manufacturing Practices) Quality Control (QC) Audit
  • Applied Medical
    Production Associate- Labeling Dept.
    MEDICAL
    January 2018 - January 2021 (3 years)
    Amersfoort, Netherlands
    • ● Analyzing errors in processes or products.
    • ● Checking counts.
    • ● Checking printed material.
    • ● Coordinate and conduct label inspections.
    • ● Execution of cleanroom activities
    • ● Overseeing the disposal of defective or contaminated products
    Labeling & Packaging Control Quality Control (QC) GMP (Good Manufacturing Practices) Cleanroom Operations Process Accuracy & Inspection

Recommendations

Be the first to recommend Lili

Help this freelancer shine by sharing your experience working together.

These freelancer profiles also match your criteria

AgathaA

Agatha Frydrych

Backend Java Software Engineer

4.7

(3)

2

BaptisteB

Baptiste Duhen

Fullstack developer

4.6

(4)

5

AmedA

Amed Hamou

Senior Lead Developer

4

(2)

7

AudreyA

Audrey Champion

Web developer

4.3

(3)

4

Education

  • Bachelor of Science in
    University of Perpetual Help
    1994
    Bachelor of Science in
  • University of the East

Skill set

Categories