Beschreibung
Electronicalengineer/Elektroingenieur oder Elektrotechniker FHElectrical - Quality & Validations Engineer (Medical Device)
For my client, part of a global Medical Device Manufacturer, I am currently looking for a specialist in Electrical Quality Engineering, managing Complaint investigations, FMEAs and supports Projects related to Manufacturing, Validation and Process improvement, as well as Audits and Compliance (MDR)
- Location: Central Switzerland
- Duration: minimum 6 months, with potential extension
- Departments: Quality Management/Engineering
- Activities: Technical Complaint Investigations, Validations, Process improvements
Electrincal- Quality & Validations Engineer
Main Responsibilities
- Responsible for Root Cause Analysis and complaint investigations for medical soft- and hardware applications
- Managing tests and technical improvements related to Product Failures and FMEAs
- Works closely with R&D and Manufacturing Engineering on Design and Process Validations and Qualification of Equipment
- Evaluate, review and approve Validation and Qualification plans and reports and Risk files
- Responsible for complete handling of Electrical and mechanical parts returned from the field for complaint investigations
- Analyze and report trends and statistical data from investigations with R&D and company management
- Responsible for providing support and communication with external customers to resolve quality issues and other related product concerns
The profile
- Bachelor or Master's Degree in Electrical Engineering or similar education
- 3 years of experience in a similar position in a highly-regulated environment, preferable in Med-Tech industry
- Good knowledge of the Med-Tech Industry regulations (ISO13485/ FDA 21CFR820 / GMP) or other highly regulated industry
- Expertise for failure investigations in soft- and hardware applications
- Experience in active device and knowledge of its Standards e.g IEC 60601
- In-depth experience in process and test method validation (TMV, IQ/OQ/PQ) and in the application of statistical methods
- Experience in Project Management
- Experience with CAPA processes
- Experience in communication with customers and suppliers
- Very good written and spoken knowledge in English and preferably in German
Should you be interested in a hands project in Central Switzerland, in a global Medical Device company? Kindly get in contact with me and send me your updated CV.
I am looking forward to hear from you,
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.