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Staff Specialist, Quality Management Systems
- Cork, Cork, Ireland
- Cork, Cork, Ireland
About
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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Languages
- English
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