Staff Specialist, Quality Management Systems

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

• Bachelor'sDegree-Level 8 Science or Engineering
• EQFLevel6orequivalent- EU
• Minimum 4 years of experience in a Quality/Regulatory Affairs function