Quality Manager Operations (m/w/d)

Your mission

Ensures that standardized processes (SOPs) are established, implemented, and consistently followed across key operational areas, including hiring, procurement, and other critical business functions. This role is responsible for embedding quality principles and ISO standards within daily operations, ensuring compliance, efficiency, and continuous improvement.

Implement and monitor quality standards according to ISO13485 and ISO27001, ensuring efficiency and compliance across departments.
Partner with teams including Operations, Finance, HR, Product and Tech teams to embed quality principles.
Work closely with Product and Tech teams and external regulatory consultants to ensure quality standards are consistently applied across all initiatives.
Identify gaps, streamline workflows, and implement best practices to improve operational performance.
Ensure adherence to internal policies, industry regulations, and audit requirements.
Track key quality metrics, generate reports, and provide insights for process improvements.
Prepare necessary documentation for internal and external audit processes.
Organize internal workshops and lead training sessions, promote quality awareness, and foster a culture of accountability.
Stay up to date with the latest quality standards

Your profile

Required experience

3 to 5 years in quality management or internal audit with a strong focus on process improvement.
Strong knowledge and working experience in in setting up and maintaining an eQMS according to ISO13485.
Experience working across multiple business functions, ensuring quality and efficiency in operations.
Strong ability to collaborate with diverse teams and translate business needs into quality-driven strategies.

Qualification & Skills

Experience with operational audits, risk assessment, and process optimization.
Proven ability to streamline workflows and implement scalable solutions.
Familiarity with setting up and working with eQMS (Qualio, MasterControl, Vera ..)
In-depth knowledge of ISO13485 and ISO27001, including Risk Management best practices under ISO14971
Experience in defining and tracking relevant KPIs
Data-driven approach to quality assessment and performance measurement.
Start-up experience

Good to have

Experience in startups in the healthcare, pharmaceutical or other heavily regulated industry.
In-depth knowledge of CE-IVDR in EU, and/or LDTs in US
Experience and certification as PRRC

Why us?

The opportunity to make a real difference for cancer patients.
Competitive salary, stock options, and extra benefits.
A beautiful office near Alexanderplatz with an on-site gym, private showers, free drinks and snacks, rooftop bar, co-working space, and a quiet room for meditation or prayer.
Competing at the global top-tier of cancer research together with the founders, who are renowned researchers in the field of AI for biomarker development from medical imaging.
An extremely fast-paced and high-growth VC-funded start-up environment with key ownership from day 1.

About us

StratifAI is an innovative Berlin-based precision oncology startup developing the next generation of AI-based cancer biomarkers. The founders have published over 100 articles in top-tier journals and founded StratifAI to translate these novel ideas into patient care.

Our products enable cancer patients to receive the right treatment at the right time - both for existing drugs on the market, and by supporting pharmaceutical companies in developing the drugs of tomorrow.