Head of Quality Management

Vor 5 Tagen

München, Deutschland Ebenbuild Vollzeit

**Your mission**:
We want you to join our early-stage university spin-off that has just received it’s ISO 13485 certification. As an integral part of our team, you will harness your quality management expertise to
- bring the Quality Management System (QMS) to the next level, by being the advocate for quality and managing the QMS.
- act as our Quality Management Representative.
- enable our vision of a Software as Medical Device (SaMD) developed in an agile manner that allows us to respond to customer feedback rapidly.
- plan and carry out the extension to an integrated Information Security Management System (ISMS) according to ISO27001.
- act as the facilitator of high customer satisfaction while ensuring a low-risk medical device.
- join part-time with the option of changing to a full-time position as the company grows.

**Your profile**:

- 5+ years of experience in Quality Management and Information Security for Medical Devices, with proven expertise in establishing QMS/ISMS frameworks.
- Proven track record of designing and implementing QMS/ISMS frameworks compliant with ISO 13485 and/or ISO 27001, ideally in startup or agile environments.
- Experience in managing software development under IEC 62304 & 62366 is highly desirable.
- Ability to make processes work for people.
- Excellent written and verbal communication skills in English. German is a plus.
- A strong aversion to doing repetitive things manually.

**Why us?**:

- Central office in the heart of Munich
- Office-based role with flexible work-from-home scheduling
- Build products that will have a measurable impact on the lives of patients
- Play a significant role in shaping the quality management system
- We are an interdisciplinary team of highly motivated, skilled, and ambitious people. Individual contributions count a lot

**About us**:
We are a Munich-based startup building a digital twin platform for respiratory diseases - a monolithic digital toolset that elevates the actions of decision makers in healthcare and life sciences through physics-based simulation, AI, and data science. In the hands of industrial users, it fosters their understanding of pulmonary drug delivery to inform, accelerate and de-risk trial design and execution. In the hands of physicians, it will offer personalized treatment perspectives to improve the odds of survival and recovery in millions of cases of respiratory complication each year, such as Acute Respiratory Distress Syndrome (ARDS). Anywhere at any time.

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