Taking the role of Quality Management Representative (“Qualitätsmanagementbeauftragter”): You take the responsibility for the QMS including document control, creation, revision, and approval of QMS documents in compliance with regulations.
CAPA management: You ensure identification, recording and actions taken related to nonconformities, safeguard processing of CAPAs, and driving the execution of CAPA related tasks.
Internal and external audits: You organise internal and external audits and represent the company and manage all audits.
Training: You provide QMS trainings to our employees, and coach and support teams in the application of the QMS.
Management Review: You organize the management review and present parameters for evaluation of compliance and effectiveness of the QMS.
Support creation and review of the technical documentation according to the requirements of EU 2017/745 (MDR), non-EU country regulations, US FDA 21 CFR and medical device regulations of other regions.
Risk Management: You conduct the risk management for Smart Reporting products according to ISO 14971.
In your role, you will report directly into the C-Level.
You have prior experience in Quality Management for Medical Devices, have contributed or lead building/maintaining a QMS, and have actively participated in internal and external audits
You are familiar with ISO 13485, European Medical Device Regulation, ISO 14971, norms like ISO 62304, ISO 62366, corresponding guidance documents and their application
You are confident to find the right balance between building an audited QMS for Software as a Medical Device while keeping it lean for swift and agile operations
You feel comfortable with the coordination of processes and guiding your colleagues in the application of the QMS
You are business fluent in English and you have strong overall communication skills; German skills are considered a plus
Have an insight to all departments of a fast-growing scale up company
Bring in your own ideas and experience, help set up structures
Build a design system within an innovative product in Healthcare IT
Flexible working arrangements: Hybrid work (Remote/ Munich Office) and flexible working hours (part-time possible)
30 days paid vacation
A variety of employee benefits: Workation, Company Events, Jobrad and LinkedIn Learning