Work Flexibility: Hybrid or Onsite
This is a permanent Hybrid role in our Anngrove site with full Stryker benefits.
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.
- 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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Travel Percentage: 10%
