Scientifically sound, practically implemented
A robust quality management system (QMS) forms the backbone of every successful company. However, quality requirements should not restrict agility and competitiveness, but should be seamlessly and efficiently integrated into the company’s processes. As an auditor and consultant, I support you in aligning your system in such a way that it creates real added value for your product quality, your employees and your position in the life science and in-vitro diagnostics markets.
Dr. Sandra Gendreau-Schumann
ISO 9001
An effective QMS creates transparency, increases efficiency and promotes active quality awareness in all areas of the company.
ISO 13485
ISO 13485 forms the basis for safety, transparency and trust, both internally and externally.
From analyzing existing processes and establishing a clear documentation structure to preparing for internal and external audits, I help you to design your QMS in a practical, efficient and standard-compliant manner.
Customized quality strategies for sustainable success
For you this means:
Safety
Your organization meets the relevant standard requirements (ISO 9001 / ISO 13485) and is optimally prepared for audits.
Trust
An ISO 13485-compliant quality management system strengthens your credibility with customers, partners and notified bodies.
Efficiency
Through targeted process optimization and a lean documentation system, you can reduce effort, osts and throughput times.
My range of services
The focus is not on pure documentation, but on practical optimization and continuous improvement, always in the interests of your customers and employees*.
Audit-related services
• Planning, coordination and implementation of internal audits
• Document review for targeted preparation for external audits
• Evaluation of your quality management system including practical advice
Supplier-related services
• Support in the planning and implementation of supplier audits
• Review and advice on supplier and quality contracts
Workshops & Seminars
• Introduction to ISO 9001 and/or ISO 13485
• Interactive workshops & seminars: “Active Quality awareness: What does quality mean to me and in my role?”
„Mastering Design Transfer: A bridge between development and manufacturing”
Supplementary services
Thanks to many years of experience in product management, I can also support you in defining customer requirements and user needs. I also create professional product and training presentations for you and support you throughout the entire product life cycle.
*My services relate exclusively to quality management and related topics; I do not provide regulatory advice.
About me
With over 20 years of experience in the biotech and IVD industry, I have a holistic view of business processes and quality requirements. Having worked in technical support, sales, marketing and manufacturing, I have first-hand knowledge of the requirements of different business areas.
I see quality management as a connecting element between strategy, operational implementation and corporate culture.
Training & Qualifications
Dr. phil. nat. in Pharmacy (Biochemistry), Goethe University Frankfurt am Main
MBA International Business, University of East London
Quality representative for medical devices – ISO 13485 (DGQ)
Auditor, Quality Officer ISO 9001 & Quality Manager (TÜV-certified)
Agile quality management (LVQ Weiterbildung und Beratung GmbH)
Languages: German and English (fluent), French (mother tongue)
Professional experience
Mainz Biomed Germany GmbH (2022-2025) – Associate Director Product Marketing
QIAGEN GmbH (2005-2022) – Associate Director Product Management IVD Instrumentation (DNA/RNA purification & qPCR)
Senior Operational Product Manager (Design Transfers)
Manager Strategic Alliances & OEM MDx (Europe and USA)
Senior Technical Service Specialist
Personal Interest
Time with my family is particularly important to me. I find balance and new energy when I play the piano. I also volunteer in local politics and regularly read aloud in a retirement home.
Contact me
Interested in working with me?
Every company is unique, and this also applies to its quality management. That’s why I offer you, as part of a free needs analysis together to find out where your company currently stands and which steps make sense to further develop your quality management system in a targeted manner. Whether virtually or on site, I take the time to understand your requirements in detail and then draw up a tailor-made offer.
Send an email with your full name and phone number to the following email address: info@gsch-qm-consulting.de, and I’ll get back to you right away. I look forward to support you.