Change Control Specialist

ThoratecSwitzerland GmbH is part of Abbott Laboratories one of the worlds leading companies in medical devices and healthcare. We are the global market leader for implantable and extracorporeal blood pump systems based on magnetic bearings. Our lifesaving medical devices which are developed and produced on-site in Zurich are used for the short- and long-term treatment of patients suffering from severe heart disease.

Our Zurich site employs approximately 150 people covering areas including R&D and manufacturing. Currently we are expanding our innovative and high-caliber team inZurichand an exciting opportunity exists for a motivated and talented software engineer.

Change Control Specialist - Medical Device

As part of theprocess engineeringteamyouwillsupport the team increating editingand managingthe documentationregardingmanufacturing processes part specificationsinspection procedures and the design.Youwill help themanufacturingteam to ensure that theproduct and project documentsare properlymanaged and traced andapproved by the managementand all changes to the product or processarecorrectly reflected inallmodified documentation.This positiondoes notrequiresper se a strong technicalbackgroundbut good understanding of MedTech/Pharma environmentgoodcommunicationskillsand an independentproblem-solvingmindset.

Main Activities

• Create edit manage andmodifyallproduct and process documentationusingPLMand ERPsoftwarepackages.

• Be a part of theprocess engineeringteam with extensiveinteractions with theR&DandQuality departments.

• Ensure traceability andcompliance of the documents with the Quality templates and instructionsas well asglobalregulatory requirements.

Qualifications

• TechnicaldegreesinTechnical/scientificfields.

• 3to6years of experienceinEngineering Quality or Technical Writingat a manufacturing environment.

• Experience with medical device manufacturingof electro-mechanical equipment.

• Good written and oralEnglishcommunication skills. Germanspeakingan advantage.

• Previous experience withsomePLMandERPsoftwarepackagesideally withWindchilland SAP.

• Familiarity withITdata servicesandregulated documentauthentications andsafeguards.

What We Offer

• A challenging position in a fast-growing crisis independent industry

• To become part of a young dynamic highly educated highly skilled and motivated team

• Flat hierarchies open appreciative mentality and efficient constructive lines of communication

• Multi-national environment where we foster the development of our talents within the enterprise

• Competitive compensations and benefits

• A workplace in thecentreof Zurich with R&D and manufacturing under one roof

Looking forward to receiving your application documents including CV motivation letter and job certificates in PDF format.