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Stellenbeschreibung

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 Expert – Medical Device Validations and Qualification

based in Zürich or one of our other affiliates in Europe.

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 or similar education, Engineers strongly preferred but not a must have


• 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.

     

Job-Familie

Operations Quality

     

Division

CAHF Cardiac Arrhythmias & Heart Failure

        

Standort

Switzerland : Technoparkstrass 1 CH 8005

     

zusätzliche Standorte

     

Schichtplan

Standard

     

Reisen

No

     

Medizinische Kontrolle

Not Applicable

     

Wichtige Tätigkeitsbereiche

Not Applicable