Senior Change Management Specialist, QMS Lead

Stryker Group; Cork; Hybrid; EUR 62,000 - 105,000; Full time

Job summary

Stryker Group in Ireland is seeking a Senior Staff Specialist, Change Management for a permanent Hybrid role at Springhill. You will lead changes to the quality management system, provide technical guidance, and drive improvement across local and franchise levels.

You will manage Change Control forums, mentor teams, and coordinate audits and KPI reporting to ensure regulatory compliance and business performance.

Qualifications

• Bachelor’s Degree Sciences or Engineering (Level 8).
• Minimum 6 years experience in a Quality/Regulatory Affairs function.
• Profound knowledge and understanding of US, European and International Medical Device Regulations (ISO 13485, MDSAP, and CFR Part 820 Quality System Regulations desired).

Responsibilities

• Leading and reviewing changes to processes and procedures with attention to regulatory compliance.
• Lead & execute Change Control forums in multisite and global forums.
• Act as SME on change control procedures and systems (OnePLM, Agile); franchise Change Control Process Owner.
• Provide input to global procedures and future changes in QMS.
• Mentor change owners and initiators.
• Manage site change control KPIs including reporting for quality and business review bodies.
• Develop Change Control KPIs and support process improvements.
• Lead audit preparation for all areas of QMS and mentor teams in audit performance.
• Support training in change control process and systems delivery and access.
• Drive continuous improvement to increase efficiency of QMS and participate in cross-site projects.
• Participate in optimization of interfaces in projects like production transfers, mergers and acquisitions.

Education

Bachelor’s Degree Sciences or Engineering (Level 8)

Job description

Stryker Group in Ireland is seeking a Senior Staff Specialist, Change Management for a permanent Hybrid role at Springhill. You will lead changes to the quality management system, provide technical guidance, and drive improvement across local and franchise levels.

You will manage Change Control forums, mentor teams, and coordinate audits and KPI reporting to ensure regulatory compliance and business performance.