Abbott Senior Quality Engineer – Manufacturing in Zurich, Switzerland
Thoratec Switzerland GmbH is an Affiliate of Abbott Medical and takes care of the development and manufacturing of our mechanical circulatory support devices, that are designed to support a broad range of advanced heart failure patients. To complete our team in Zürich, we are looking for a
Senior Quality Engineer – Manufacturing
Be part of a team that is responsible for the manufacturing and testing of life-supporting medical devices that are based on magnetic levitation technology. You can help us to assure that we manufacture according to all standards and internal procedures with a high focus to assuring the quality of our products.
Validate and qualify devices and processes
Prepare quality-related documents to comply with the regulatory requirements of the Med-Tech industry
Support problems and questions arising in the production or in the other areas of the organization (also internationally) and propose adequate solutions
Investigate to highlight errors and deviations, perform root-cause analysis and implement effective corrective actions (CAPA and NCMR)
Manage, implement and monitor corrections and corrective actions to resolve non-conformances
Participate in internal and external audits
Work closely with suppliers on manufacturing matters
Master's Degree in Mechanical, Electrical or Industrial Engineering (ETH/FH or comparable education)
3-5 years of experience in a similar position in a highly-regulated environment, preferable in Med-Tech industry
Very good knowledge of the Med-Tech Industry regulations (ISO / FDA / GMP)
In-depth experience in process and test method validation (TMV, IQ/OQ/PQ) and in the application of statistical methods
Experience with CAPA and non-conformance processes
Very good written and spoken knowledge of German and English
Do you like the sound of this job and think you’ve got what it takes? Then send us your CV today. We look forward to receiving your application as pdf.
(If you want to upload several documents, don`t save in between uploading them to be able to do so. Once you save your uploads, you will not be able to add more documents)
Discover at http://bit.ly/workingatabbottswitzerland why candidates choose a career at Abbott Switzerland.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org