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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
Details:
Start: Asap, 1st of August 2025
Duration: 13 motnhs
Hours per week: full-time (40 hours / week)
Location: 50% onsite in North Germany / 50% remote
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