Freelancer, Full-time · Berlin
We are looking for a freelancer or consultant who wants to join us as a Digital Quality Management Officer (m/f) in Berlin.
As a Digital Quality Management Officer at Mimi you will:
Be the "evangelist" and coordinator of the Quality Management System for medical devices based on ISO 13485.
Check whether all standard operating procedures (SOPs) and technical documentations required by regulations have been created.
Write SOPs or assisting process owners.
Write and update the quality management manual.
Check existing SOPs for compliance with regulatory requirements.
Monitor whether Mimi works according to its own SOPs and carry out internal audits.
Create an audit program and an audit plan and document the results in an audit report.
Coordinate and carry out external audits with the Notified Bodies.
reporting to top management on the effectiveness of the quality management system and any need for improvement.
Train colleagues (including management) on the significance and functioning of their own QM system and the regulatory requir
Expertise in medical device regulation.
Experience working with software companies that use Agile and Scrum methodology.
Experience working with ISO 13485, IEC 62304, ISO 14971 and IEC 62366.
Experience in auditing companies.
Experience in training employees.
Fluent in English and German.
It would be great if you have:
Experience working with Atlassian Confluence.
Knowledge about the FDA approval process for medical devices.
An interest in audio, music, or sound.
A 3 - 6 months fixed term contract.
Potentially the option of joining us as CE 2A Quality Management officer on a permanent basis employee after the contract.
An open, airy work environment in Mitte, the heart of Berlin.
Work together with an international and diverse team.
Please fill out the following ...