Staff Specialist, Quality Management Systems

About the role

Stryker is looking for a Staff Specialist, Quality Management Systems (QMS) to cover maternity leave at its Anngrove site in Carrigtwohill, Cork. This is a hybrid role with full Stryker benefits, and the position is open for 12 months. The specialist builds and maintains the quality management system in line with regulatory requirements for medical devices, ensuring regulatory clearance and certification.

Key responsibilities

• Ensure QMS compliance with internal and external requirements, including Site, Division, Corporate, FDA, ISO, EU MDR and country-specific rules
• Develop and control the regional/local quality management system, and lead projects to build or modify it
• Manage and coordinate management reviews, quality planning reviews and internal and external audits, liaising with notified bodies on certification changes
• Support the implementation of QMS training and the development of policies and procedures
• Act as Local Process Owner for local quality system processes and support strategic improvements
• Implement best-in-class QS practices and benchmark against industry leaders and regulators
• Ensure overall GMP and GDP compliance within Quality

Required profile

• Bachelor's degree (Level 8 Science or Engineering EQF Level 6 or equivalent)
• Minimum 4 years of experience in a Quality or Regulatory Affairs function

What we offer

• Pay range in Ireland of EUR 54,000 - 90,000 per year, plus possible incentive compensation
• Hybrid work arrangement and full Stryker benefits
• Approximately 10% travel