Andreas Spitzer
Global Quality Management Consultant
Delivering precision quality systems for the global medical device industry — 9+ years of hands-on expertise.
Currently accepting new mandates — available globally for on-site and remote engagements.
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About Me
With over 8 years of experience in Quality Management, I support medical device companies worldwide in building and maintaining robust Quality Management Systems in compliance with ISO 13485, ISO 9001, and GMP standards.
Starting my career in aviation engineering, I transitioned into the medical device industry in 2017 — driven by the conviction that precision and compliance are not obstacles, but the foundation of products that save lives.
As a freelance consultant, I offer something that large consulting firms cannot: direct, unmediated expertise. No account managers, no junior staff — you work with me directly, at every stage of the project. Whether I'm building a QMS from scratch, preparing your team for a notified body audit, or stepping in as interim Head of Quality, you get the same thing every time: one experienced professional, fully committed to your outcome.
What Sets Me Apart
Nine years. Three languages. One focus.
- TÜV Süd Academy — Representative for Quality Management in the Medical Device Industry (2020)
- ISO 13485 · ISO 9001 · GMP
- 9+ Years Industry Experience
- Fluent in English, German & Spanish
- Available Globally
Specialized, Not Generalized
I don't consult on everything. My focus is Quality Management for medical device companies — deep, sector-specific expertise, not generalist advice.
An Engineer's Mindset
My background in aviation engineering is a differentiator. Aviation and medical devices share the same non-negotiable: when systems fail, lives are at stake.
Freelance Means Full Focus
No account managers, no junior consultants, no handoffs. When you work with me, you work with me — one experienced person, fully accountable for the outcome.
Truly International
Fluent in English, German, and Spanish — direct communication in the language your team speaks.
Available When You Need It
QMS gaps don't wait for convenient timing. Available for rapid deployment globally — without the overhead of a large consultancy.
Companies I've Worked With
Companies I have worked with across the medical device industry.
Experience
A career built on precision — from aviation engineering to leading quality systems in the global Medtech industry.
Entry into Medical Device Industry — Service Coordinator
First role in the medical device industry, gaining hands-on experience with service coordination, technical documentation, and the regulatory environment of medical imaging equipment.
Product Quality Engineer
Roche Diagnostics International AG
Quality engineering role at a global diagnostics leader — responsible for product quality processes, deviation management, and supplier quality across international manufacturing sites.
Quality Assurance Specialist (ad interim)
Qmedics AG
Growing quality assurance responsibility at a Swiss Medtech company. Management of the complete QMS and leadership of internal and external audits.
Head of Quality Management & QMB
Qmedics AG
Leading the quality management function and serving as Quality Management Representative (QMB). Ensuring ongoing ISO 13485 compliance and full QMS responsibility.
Freelance Quality Management Consultant
QM-Service
Independent freelance quality management consultancy serving medical device companies across Europe and beyond — specializing in ISO 13485 QMS implementation, audit preparation, gap analysis, CAPA management, and interim quality leadership.
Certifications
Professionally certified in Quality Management — accredited by leading institutions in the field.
Quality Management Representative
Certified specialist for quality management systems in the medical device industry, accredited by TÜV Süd Academy.
Risk Management for Medical Devices
Certified in risk management for medical devices — systematic hazard identification, risk estimation, risk control, and post-market risk monitoring in line with ISO 14971:2019.
Quality Management Systems
Quality management systems standard — foundation for structured, process-oriented quality assurance.
Services
Tailored quality management solutions for the medical device industry — from initial assessment to ongoing compliance support.
QMS Implementation
Building and structuring compliant Quality Management Systems from the ground up, tailored to ISO 13485 and ISO 9001 requirements.
Internal Audits
Thorough, systematic internal audits to identify gaps, ensure compliance, and prepare your organization for external certification audits.
Gap Analysis
Structured assessment of your current QMS against regulatory requirements — clear action plans.
CAPA Management
Implementing effective Corrective and Preventive Action processes to eliminate root causes and prevent recurrence.
Documentation & SOPs
Creating, reviewing, and maintaining all QMS documentation in line with regulatory standards and operational needs.
Let's Work Together
Ready to elevate your QMS to the next level? I'm available for new mandates and happy to discuss your project in a no-obligation initial consultation.