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Confidential

Staff Specialist, Quality Management Systems

Confidential
  • IE
    Cork, Cork, Ireland
  • IE
    Cork, Cork, Ireland

Über

This is a permanent Hybrid role in our Anngrove site with full Stryker benefits.
Have you got what it takes to succeed The following information should be read carefully by all candidates.
What you will do:
The Staff Specialist, Quality Management Systems (QMS) will be primarily responsible for the developmentofthequalitymanagementsysteminaccordancewithrelevantregulatoryrequirementsfor medical devices.
The Staff Specialist, QMS will oversee and ensure that an effective and efficient quality management systemisbuiltandmaintained.HasresponsibilitytoensureallnecessaryQSregulationsaremetinorder to receive regulatory clearance/ certification.
Responsible for QMS compliance with the appropriate internal and external regulatory requirements(includingbutnotlimitedtoSite,Division,Corporate,FDA,ISO,EUMDR,and individual country requirements).
ResponsibleindevelopingtheoptimumstateofQMSforcurrentandfuturebusinessneeds, aligned with Corporate, divisional & GQO QMS.
ControlandimplementationofthedevelopmentormodificationofStryker'sregional/localquality management system
Supportmanagementandcoordinationofmanagementreviewsandqualityplanningreviews
Supportinidentifyingandimplementingstrategicimprovementsandparticipationinthequality planning process
ServeasaLocalProcessOwnerforlocalQualitySystemProcesses
Responsibleforthemanagementofinternalandexternalaudits,leadingpreparationsandback room
Liaisewithnotifiedbodiestomanagecertificationchanges.
SupporttheimplementationofQMStraining
Initiateandsupportthedevelopment,maintenance,andimprovementofpoliciesandprocedures.
AssessmentandquantificationoftherequirementsoftheQMSsothatitofferstheoptimal structure for the services to be provided
Implementationofbest-in-classQSpracticesandbenchmarkingagainstindustryleadsand regulatory requirements. xyswxtq
EnsureoverallGMPandGDPcompliancewithinQuality.
Managementandimplementationofprojectstodevelopand/ormodifyStryker’sregional/local QMS, as well as providing direction for the strategy to the entire project team
What you will need:
Bachelor’sDegree–Level 8 Science or Engineering
EQFLevel6orequivalent– EU
Minimum 4 years of experience in a Quality/Regulatory Affairs function
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  • Cork, Cork, Ireland

Sprachkenntnisse

  • English
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