Change Management Lead, Quality Systems

Stryker Group; Cork; Hybrid; EUR 54,000 - 90,000; Full time

Job summary

Stryker is seeking a Staff Specialist, Change Management, to oversee changes to the quality management system and lead cross-functional teams across sites. You will act as SME for change control and coordinate reviews, ensuring compliance and continuous improvement.

The role requires a strong background in regulatory affairs, ISO 13485, MDSAP, CFR Part 820, and hands-on training of teams through change processes within a hybrid Ireland-based setup.

Qualifications

• Bachelor’s Degree in Sciences or Engineering.
• Minimum 4 years experience in a Quality/Regulatory Affairs function.
• Profound knowledge of US, European and International Medical Device Regulations.
• Regulations ISO 13485, MDSAP, and CFR Part 820 Quality System Regulations desired.

Responsibilities

• Oversee and assess changes to the quality management system.
• Lead change control board reviews and coordinate multi-site forums.
• Serve as SME for change control procedures and systems (OnePLM, Agile).
• Provide input into global procedures and train users on change control processes.
• Collaborate with Design, Quality and Operations on change-related activities.
• Mentor teams through all stages of change management and KPI reporting.

Skills

Change management

Regulatory knowledge

Cross-functional collaboration

Training & coaching

Education

Bachelor’s degree in Sciences or Engineering

Tools

OnePLM

Agile

Job description

Stryker is seeking a Staff Specialist, Change Management, to oversee changes to the quality management system and lead cross-functional teams across sites. You will act as SME for change control and coordinate reviews, ensuring compliance and continuous improvement.

The role requires a strong background in regulatory affairs, ISO 13485, MDSAP, CFR Part 820, and hands-on training of teams through change processes within a hybrid Ireland-based setup.