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Schwerbehinderte Bewerberinnen und Bewerber werden bei gleicher Eignung besonders berücksichtigt.

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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

Quality Assurance and Project Manager

Summary

• Initiate and manage projects to ensure continuous product and process optimization


• Managequality control department- and quality project team within the quality organization


• Analyzesaspectsofandexecutesquality-assuranceactivitiesto ensurecompliancewithinternalprocedures andexternalstandardsandregulations.


• Leadandguidethe activitiesof the qualityorganizationwithresponsibility for resultsintermsofproductquality,performance,andsafety.


• Providesguidance,supportandcommunicationwithOperations,R&D/Engineering,andcustomers to resolvequalityissuesandother relatedproduct concerns within the quality control area


• Support problems and questions arising in the production or in the other areas of the organization (also internationally) and propose adequate solutions


• Lead projectsandprovides support and communication with Operations andR&D/Engineeringto achievesuccessfulclosure.


• Activelydrivesalldefinedqualitysystemsgoalsandobjectivesat the plantlevel.


• Work closely with manufacturing engineering, operation and internal supply chain team to ensure product release on time to provide customer satisfaction


• Investigate to highlight errors in manufacturing- and quality control area as well deviations, perform root-cause analysis and implement effective corrective actions


• Establish the site training plan and be the training SME to be compliance with any external regulatory requirement


• Lead periodically SOP/document review activity through the whole Zurich organization

DutiesandResponsibilities

Project Management

• Manage quality site specific project goals.


• Create site project plan align with the global mile stone.


• Ensure mile stone achievement with frequent reporting to site quality head.


• Collaboration and connect with global quality team to be aligned with any project and change direction as needed.

Leadership.

• Managesandleadsquality control team (upto 5),setindividualgoalsderivedfromcompanygoalsandobjectivesandsupportspersonnelto meet the goals.


• Takeresponsibilityinassigningtasksandallocatesresourceswhereneededtoachievethesegoals.


• Monitorsandguidespersonnel to ensureefficient,accurate,andcompliantworkofpersonnel.


• Build up train a new Quality Control leader from current Quality Control team.


• Create career development plant for the quality control department.

Supervision

• Responsiblefor the training process,set up training metrics and plan for the site.


• Ensure complianceperformancemanagement,andsupervisionofqualitycontrolteam for Zurich

Audit

• Connect and cooperate with the Abbott Quality and Regulatory (AQR) department for knowledge exchanging to collect newest regulatory changes.


• Create audit behavior training for the whole site in Zurich to achieve great outcomes for any onsite audits.


• Lead and present awareness training of ISO 13485, FDA, MDR and audit readiness preparation.


• Manage the audit readiness preparation work for all departments on site.   

Quality integration

• Track together with quality system manager the ONE quality system integration activity according the global plan.

Data Management

• Data collecting of QDR (Quality DATA Review) from different stakeholders on a monthly base.


• Quarterly data collection of MRM (Management Review Meeting).  

Quality System Procedures

• Assists in the development and administration of quality control procedures and activities to ensure products and processes are in compliance with quality standardsandregulations.

ProductAcceptance

• Supportsproductacceptanceactivities.


• Reviewsproductionrecordswith the quality control team and all related stakeholders to reduce non conforms and improve GDP-  complianceofdocumentationandrelatedprocessesandmakesfinal decisionon the releaseofacceptedproduct.

Non-conformingProduct

• Overseesthe evaluationanddispositionofnon-conformingproductandprocessesidentifiedduringproductioninorotherquality controlprocesses.


• Participatesinroot-causeinvestigationsrelated to (internal)quality control.


• Analyzesandescalatesissuesin a timelyfashion to the site quality head.

General

• Performsotherdutiesasassignedby the Senior Quality Manager


• Organizesandmoderatesprojectsrelated to qualityandany cost reduction activity


• Supports and leadotherdepartmentsasqualityspecialistin Quality andnon-qualityrelatedprojects.


• Works closelyandproactivelywith the Quality Engineer – Quality, Regulatory & Compliance  Manager to maintainandtoimprove the qualitysystem,it’sintegrationwithcompanywidequalitysystemsandalignmentwithallapplicablestandardsandregulations

Qualifications

• MasterdegreeinScience,EngineeringorotherTechnicalfieldisrequired.


• Minimum fiveyearsofrelatedexperiencein quality for medicaldevicemanufacturingenvironment.


• In-depthknowledgeofISO, European, GMP, MDR. GDPandUSregulationsrelated to medicaldevices


• Experienceinsupervisoryposition and project management within different departments


• Minimum five year people leadership in people management


• Comprehensiveunderstandingofinternationalanddomesticmedicaldeviceregulatoryguidelines.


• Proficiencywithpersonalcomputers, businessandtechnicalsoftware.


• Veryprofessionalandeffectiveverbalandwrittencommunicationskills(EnglishandGerman).


• Canworkself-organizedaswellaswithremoteorganizations(USfacilities)


• Excellentorganizational,time management,andmulti-taskingskills.


• Abilityto workin a team environmentusingeffectiveinterpersonalandnegotiationskills.


• High ethicalstandardsandcanget thingsdone.

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

EPHF Electrophysiology & Heart Failure

        

Standort

Switzerland : Technoparkstrass 1 CH 8005

     

zusätzliche Standorte

     

Schichtplan

Standard

     

Reisen

No

     

Medizinische Kontrolle

Not Applicable

     

Wichtige Tätigkeitsbereiche

Not Applicable