Global QMS Technical Lead: Supplier & Sourced Devices

GxP Recruitment; Galway; On-site; EUR 110,000 - 170,000; Full time

Job summary

GxP Recruitment seeks a Global QMS Technical Process Lead to drive supplier controls and sourced device/material controls within broad regulatory programs. You will assess, design, implement, and continuously improve enterprise QMS processes supporting AI-enabled, cloud-based, and SaMD initiatives.

You will lead cross-functional workshops, coordinate stakeholders, and manage action items to ensure timely delivery of supplier quality improvements across multiple initiatives.

Qualifications

• Seven (7) or more years of experience in Quality Systems or related quality functions within a regulated industry.
• Experience assessing, designing, implementing, and improving QMS processes.
• Experience with supplier assessments, supplier controls, and outsourced process controls.

Responsibilities

• Lead the assessment, design, implementation, and continuous improvement of Supplier Controls and Sourced Device/Material Controls.
• Drive cross-functional workshops and coordinate stakeholders to progress supplier quality initiatives on project timelines.
• Assess and enhance supplier assessment, lifecycle management, change management, and risk management processes.
• Develop and implement QMS procedures, work instructions, templates, and quality records to sustain supplier quality.

Skills

Quality Systems

Supplier Quality

Supplier Controls

Sourced Device Controls

Regulatory Compliance

Education

Bachelor's degree in Engineering/Quality/CS/Cybersecurity/Software Engineering/Life Sciences

Job description

GxP Recruitment seeks a Global QMS Technical Process Lead to drive supplier controls and sourced device/material controls within broad regulatory programs. You will assess, design, implement, and continuously improve enterprise QMS processes supporting AI-enabled, cloud-based, and SaMD initiatives.

You will lead cross-functional workshops, coordinate stakeholders, and manage action items to ensure timely delivery of supplier quality improvements across multiple initiatives.