Our Team

From internal audits, QMS remediation, and audit preparation to anything else that falls within the scope of QM in your company- we at incantis roll up our sleeves and take you further!

Julia Wolfrat

CEO / Senior Consultant

Julia leads our team as CEO. Therefore, her work mainly focuses on the further development and growth of the company.

Naturally, she brings her 10 years of experience in the medical device industry into play when it comes to finding pragmatic solutions for our customers. In her day-to-day project work, Julia is primarily involved in creating and implementing new qulity management systems for smaller medical device manufacturers and startups. She is also involved in the revision of existing systems that are no longer efficient. She is known for flexible processes that are tailored to specific needs while ensuring compliance with industry standards such as ISO 13485, MDR and 21 CFR 820. 
Her daily routine also includes the validation and qualification of large industrial plants or the software tools used by customers.

Sandra Poloczek

Team Lead Business Development 

Sandra works as Team Lead for Business Development alongside Julia, our CEO.
The main part of her job consists of working with Julia to set up, develop, and improve ideas and processes to advance incantis GmbH.
In her daily work, Sandra can pursue her passion for Sales, Marketing and HR.
Her tasks include recruiting, direct sourcing, HR development, administration and communication.
Sandra brings years of experience in sales to build a sales network and plan events and collaborations. She develops sales, marketing and social media strategies and oversees the company's external appearance and communication.


Jan Wolfrat

IT Support / Prokurist


As a trained IT specialist, Jan is our go-to person for anything related to IT or technology. He manages a very important part of our work, ensuring that collaboration within the team runs smoothly. 
We place great importance on securely storing our customers‘ data and making communication in projects comfortable and effective for everyone.

Jan supports the team as needed and, together with Julia, takes responsibility for incantis‘ strong commitment to social engagement. 
He maintains contacts with nonprofit organizations, schools and kindergartens to idetify support needs.

Myriam Meier

Quality Consultant / Teamlead

In early 2022, Myriam transitioned from the rail and aviation industries to the medical device sector, joining incantis. 
Despite being new tot he medical device field at that time, Myriam was able to dive right into quality management thanks to her nearly 10 years of experience.

Her main focus is document control and establishing various processes. 
Additionally, Myriam supports our customers in the execution, monitoring, and follow-up of various operational topics such as CAPA, NC  and change management.


Fotios Soumelidis

Senior Quality Consultant

Fotios, with his scientific background as a biologist, brings nine years of experience in the GMP sector. Specializing in the pharmaceutical industry, with a focus on ATMPs, he undertook various general QM activities throughout his career, including the preparation of qulification documents for equipment and systems. 
Due to his high IT affinity and close collaboration with IT departments, he has developed into a strong interface between QM and IT over time, focusing on CSV. 
In his project work, Fotios is involved in conducting risk analyses and validating computerized systems, as well as preparing the necessary qualification documentation.

Florian Maier

Quality Consultant

With over 20 years of experience in the industry and various positions such as Technical Manager, QMB, Business and Development Manager, Florian possesses extensive knowledge in quality management in general, as well as specifically in production-related aspects.

 


Andrea Wonner

Quality Consultant

Andrea is part of our team as a Quality Consultant. 
Since her studies in medical technology, she has been supporting and advising clients in the medical device industry, actively developing and implementing problem-solving strategies with increasing experience and a hands-on mentality.

Together with the various departments of the clients, Andrea works on implementing or revising their QMS processes. 
In addition to Quality Assurance, she has also gained a foothold in Regulatory Affairs. 
Her responsibilities include technical documentation, risk management, and preparation for product approvals, with a focus on 510(k)s in her project work. 
She deals with medical devices of all classes, with a particular interest in software as a medical device. No amount of documentation is too large for Andrea to navigate, and she is eager to take on new tasks where she can apply her growing experience.


Katja Jakubowski

 Associate Quality Consultant

After completing her biochemistry studies, Katja developed a passion for quality management in laboratories, healthcare and the medical industry. 
For nearly five years, she successfully led the qulality management of a medical care center with a virological laboratory.

As a result, she is well-acquainted with the operational requirements according to ISO 9001 and ISO 15189, the implementation and harmonization with a day-to-day parcatice and labortaory activities, as well as long-term solutions and further developments. 
Since october 2023, she has been broadly applying her experience at incantis. Katja is currently involved in various projects behind the scenes and supports the team, especially when things need to be done quickly and accurately. 
She has a particular affinity for facts, data and figures, as well as their appealing presentation in graphics. She enjoys defining SMART goals, clear processes and transparent areas of responsibility.


Isolde Hientz

Quality Support

Isolde began her professional career in ISO 9001 certified companies and most recently spent several years learning the processes in an ISO 13485 regulated company in the medical device industry before joining incantis GmbH. 
As a newcomer to quality management, Isolde has ventured into new territory and has been successfully delving deeper into the subject matter since September 2023.

She is a member oft he operational team supporting areas such as change management, document control, NC, and CAPA management. 
The range of tasks is diverse and gives Isolde the necessary leeway to freely develop over time in terms of further development and training. 
Wherever help is needed, she is there with enthusiasm to advance both incantis GmbH and its customers.


Christine Wimmer

Senior Consultant

Christine, as a Senior Consultant, has probably conducted, processed and updated more risk analyses in her career than our entire team combined.

As the original founder of incantis, she brings extensive experience in both development and QMS, supporting our clients with topics such as specifications and traceability.
She also plays a psychological role, helping our team avoid despair, no matter how complicated the Excel problem.


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