Basel, Basel, Switzerland
I am a Global Quality Leader driven by a single mission: ensuring patient safety through the delivery of high-quality medical devices and drug-device combination products. Currently serving as the Global Device Quality Team Lead at Roche, I lead a high-performing quality organization that balances global strategic oversight with deep technical engagement across the entire product lifecycle. My work spans the full end-to-end journey of our portfolio—from early-stage development and industrialization through to the commercial phase. By staying hands-on with technical quality oversight and design assurance, I ensure our innovations meet the highest global regulatory standards, including ISO 13485, 21 CFR 820, and the EU MDR. Central to this is a rigorous, multi-disciplinary approach to Risk Management according to ISO 14971, ensuring robust product design and patient safety at every stage. As a leader within the Roche global ecosystem, I am dedicated to the VACC (Visionary, Architect, Catalyst, Coach) model. I lead and mentor a global team of 8–12 Quality Specialists, fostering an inclusive environment where we challenge the status quo to achieve "Right to Operate" with a lean, customer-oriented mindset. Core Focus Areas: Quality & Design Assurance: Providing global end-to-end technical oversight for combination products during development, industrialization, and commercial phases. Risk Management Leadership: Driving strategic quality objectives and leading multi-disciplinary risk management activities in full compliance with ISO 14971. Global People Leadership: Coaching and empowering a global team of Quality Specialists to reach their full professional potential while achieving global organizational goals. Technical Leadership: Serving as a Subject Matter Expert (SME) for design assurance and risk management to ensure compliant and reliable product launches. Global Strategic Partnership: Collaborating with internal stakeholders across the global organization to drive quality objectives and support critical business needs
• Global Leadership & People Management: Lead, mentor, and coach a global team of 8–12 Quality Specialists using the VACC model (Visionary, Architect, Catalyst, Coach) to drive professional development and achieve organizational goals. • End-to-End Quality Oversight: Maintain global responsibility for Quality and Design Assurance across the entire lifecycle of medical devices and drug-device combination products, from initial development through industrialization and commercial phases. • Multi-disciplinary Risk Management: Drive strategic quality objectives and lead complex, multi-disciplinary risk management activities in strict accordance with ISO 14971, ensuring robust product design and patient safety. • Quality Governance & Strategic Partnership: Act as a tactical and strategic quality partner to global internal stakeholders, serving on governance teams to establish realistic quality goals and metrics while providing quality leadership to Subject Matter Experts (SMEs). • Technical Quality Leadership: Serve as a global SME for design assurance and risk management, providing technical quality oversight for design and process transfers to ensure the delivery of safe, compliant, and reliable products.
Working as a Quality Single Point of Contact (QSPOC) in the Global Device Quality (GDQ) team. This team is responsible of all quality assurance activities during development and commercialization of drug delivery systems. In particular, this role includes: • Serving as the QSPOC for allocated Device Development projects and ensure all projects follow the applicable Risk Management procedures and ISO13485 during Design Control activities, Design History File documentation and Control Strategy definition. • Providing quality support to the device and development team during development and/or issue resolution by fostering effective interdepartmental and cross-functional partnership. Main interfaces in this context: Device Engineering, Human Factors Engineering, Verification Engineering, Process Engineering, Packaging Engineering, Technical Regulatory Affairs. • Collaborating with QA representatives (Clinical Quality Product Lead, Supplier Quality, QA validation, etc.) • Performing Risk Management Activities: Author and deploy Risk Management Plan / Report, facilitate Risk management activities (FMEAs) while ensuring adherence to Roche applicable procedures and Standards especially ISO14971 and MDR. • Actively participating in elaboration of all design Control documents for the Quality area of expertise • Quality Oversight of change control and discrepancy management activities and associated corrective / preventive actions. • Serving as statistical subject matter expert including authoring of internal procedures and guidances and support cross functionally on statistical challenges for example using Six Sigma methodologies. • Knowledge Management including creation and maintenance of team`s shared drive and google site
Agap2 is a European engineering and operational consulting company in the Life Science area, focused on the pharma/biotechnological, medical device and chemical industry. The company has numerous professional specialists in engineering, natural sciences and pharmacy. In this role, I provided consulting services at the client`s site as a Medical Device Quality Manager for combination products.
As Technical Expertise Manager I was responsible for the support of consultants, technical project management, and internal knowledge management. In addition, I was answering to request for Information (RfI) and request for proposal (RfP) posed by clients in the pharma industry. Since June 2017 I was additionally in charge of managing one of agap2`s key pharma clients. In particular, I was responsible for: • Single point of contact between the client and agap2 for consulting services • New projects acquisition • Internal Knowledge Management • Business Development & Strategic Advisory responsibilities • Training and coaching lead • Establishing and maintenance of the agap2 Quality Management System • Interviews, recruiting and onboarding of new employees • Technical Project Management of internal projects • Support of all internal consultants
I was working on the development of new equipment for the production of fine chemicals together with my team of 6-7 technicians. When newly developed equipment was put to operation, I was responsible for the supervision and optimization of the production process.
The Fraunhofer Institute for high-speed dynamics is a facility of the Fraunhofer Society. Its activities are applied research and development in the fields of materials science and high-speed measurement techniques. The major applications are in the fields of defense, security, automotive, space and aviation. As a development engineer, it was my role to design a medical device for tumor treatment. In order to test if methods developed in the institute are also applicable in the field of medical technology, a collaboration with the university clinics was installed. In this context, I was responsible to investigate the impact of shock waves on cancer cells, including the following major activities: • Establishment and management of a Laser lab • Development and characterization of a method to generate shock waves with a short pulsed Laser • Collaboration with a team of scientists at the University clinics • Design and analysis of shock wave experiments on brain tumour cells • Technology research to further improve experimental methods • Communication with suppliers for laboratory equipment • Cultivation of living cells in an S2 cell culture lab • Writing reports for the institute and the Fraunhofer society • Publication in scientific journals A method of opto-mechanical shock wave generation was successfully established and shown to reproducibly destroy brain tumor cells. This is the basis to develop a safe and effective medical device in the future. Publications: • Steinhauser M O, Schmidt M. Destruction of cancer cells by laser-induced shock waves: Recent developments in experimental treatments and multiscale computer simulations. Soft Matter, 2014 • Schmidt M, Kahlert U, Wessolleck J, Maciaczyk D, Merkt B, Maciaczyk J, Osterholz J, Nikkhah G, Steinhauser M O. Characterization of a Setup to test the Impact of High-Amplitude Pressure Waves on Living Cells. Scientific Reports, 2014
Within the group of biological physics (Complex Systems team) the general aim of my research projects was to build a bridge between molecular properties and cellular physiology. The collaboration with biological experts from the Max Planck institute for terrestrial microbiology was essential to gain experimental insights on the bacterial system and to experimentally test our theoretical predictions. Particular tasks included: • Implementation of statistical fluctuations on bacterial growth models • Simulation of bacterial cell division processes on the molecular and cellular level • Theoretical description of the influence of statistical fluctuations on bacterial populations • Handling large amount of data with Perl • Numerical simulations of complex systems with C • Collaboration with the Max Planck Institute for Terrestrial Microbiology • Solving differential equations with numerical and analytical methods • Contribute to the university teaching activities Publications: • Schmidt M, Physical Aspects of bacterial cell division. phd thesis, 2011 • Schmidt M, Creutziger M, Lenz P. Influence of Molecular Noise on the Growth of Single Cells and Bacterial Populations. PLoS ONE, 2012 • Creutziger M, Schmidt M, Lenz P. Theoretical models for regulation of DNA replication in fast growing bacteria. New Journal of Physics, 2012