Quality Management Systems Specialist

4 days ago


Cork, Cork, Ireland Stryker Group Full time
Job Summary

We are seeking a highly skilled Quality Management Systems Specialist to join our team at Stryker Group. As a key member of our QMS team, you will be responsible for ensuring the effectiveness and efficiency of our quality management system.

Key Responsibilities
  • Ensure compliance with internal and external regulatory requirements, including FGO, Division, Corporate, FDA, ISO, MDR, and individual country regulatory requirements.
  • Act as designee for Management Representative and QMS Manager as needed.
  • Develop and implement improvements to our QMS to optimize its structure and support business needs.
  • Manage and coordinate Management Review Process and FGO Audit Program.
  • Liaise with notified bodies to manage certification changes.
Requirements
  • Bachelor's degree or Master's in Science, Engineering, or related field.
  • Minimum 4 years of experience in Quality Management Systems or Regulatory Affairs environment.
  • Strong knowledge of Quality Systems, including CAPA, Audits, Management review, and Quality Planning.
About Us

Stryker Group is a leading medical technology company committed to improving healthcare outcomes through innovative products and solutions.



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