Quality Engineer (m/w/d)

Tasks :

• Validation of CNC Milling machines

• Validate a defined article group across different processes

• Prepare complete documentation, including VP, Study (if necessary), IQ, TMV (if necessary), OQ, PQ, VR

• Monitor and ensure the quality of the entire article group from VP preparation through implementation into the QM

• Execute all relevant validation activities in accordance with SOPs

• Specify and qualify test equipment, perform process and equipment validation

• Identify and implement improvement measures

Qualification :

• Several years of experience in a regulated, high-volume industrial production environment

• Strong background in ISO 13485, ISO 9001, FDA regulations

• Medical technology experience

• Ability to develop solutions and drive improvement initiatives independently

• Excellent written and spoken English and German skills