Job description

JOB DESCRIPTION:

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

Sr. Quality Engineer - Validations and Product Analysis

Main Responsibilities

• Work 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 material returned from the field (RMA) 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 

Your 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 (ISO / FDA / GMP)
• Experience in failure investigations in soft- and hardware applications
• 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 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.

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Discover why candidates choose a career at Abbott Switzerland.

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