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Staff QMS Specialist in Ireland / Dublin at Stryker Corporation

Date Posted: 4/11/2019

Job Snapshot

Job Description

Insert detailed

Will work within the QMS team, under minimal supervision, with responsibility to ensure an effective and efficient quality management system is built and maintained, which includes, but not limited to the following:

  • Ensure the Quality Management System is in compliance with the appropriate internal & external regulatory requirements, (including but not limited to European RHQ, Division, Corporate, FDA, ISO, MDD, and individual country regulatory requirements)
  • May act as designee for Management Representative in appropriate situations.
  • Develop optimum future state of QMS for business need, aligned with Corporate, divisional & ONV QMS.
  • Identifies improvements & inputs into the quality planning process.
  • Drive development and/or modification of Stryker's regional/local Quality Management Systems.
  • Manage & Co-ordinate Management Review Process and Quality Planning Review & Forums.
  • Assess & Quantify requirements for support of QMS to optimum structure under which the service required will be provided.
  • Be a key driver of GMP and GDP practices within Quality. 
  • Identify and implement improvement opportunities to increase the efficiency and effectiveness of the Quality Management Systems.
  • Develop & deliver training/compliance for QMS group.
  • Contribute to the development, maintenance and improvements of the policies and procedures.
  • Implement best in class QS practices and benchmark against industry leads and regulatory requirements.
  • Liaise & lead conversations with notified bodies to manage certification changes.
  • Ensure QMS reflects actual activities and business needs, and supports NPD  requirements
  • In a project environment, lead and execute development and/or modification of Stryker's regional/local Quality Management Systems.
  • Co-ordinate all QA activities to ensure project milestones of assigned projects are met in accordance with QS development.
  • Provide direction on QA strategy for the overall Project group of assigned projects. Execute and oversee the Project Quality Plan of assigned projects. Proficiency in leading improvement processes, executing and leading projects, understands project stages.
  • Understand and contribute to development & generation of SRS/URS for quality related IT-systems.
  • Owner of the business process/es and understands how IT system supports those business processes
  • Has knowledge of how system functionality supports the business requirements in their business area.
  • Represents the business during audits to discuss system functionality.
  • Has understanding of the IT system validation documents for which the business has ownership, input or approval requirements (e.g. System Description, Project Management Plan, Testing Strategy, Test Summary Report, Requirements, Traceability Matrix, Validation Summary Report)
  • Strong knowledge of the system integrations
  • Is responsible for assessment and approval of change control of the system (BPO/QA approval) per regulatory and internal system requirements
  • Is responsible for user requirement generation at system implementation phase.

job description here.

Work From Home: No

Travel Percentage: Up to 25%

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