Global Cybersecurity Quality Specialist

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

The Global QMS Technical Process Lead - Supplier & Sourced Device Controls will provide dedicated support for strategic Global Quality Systems initiatives by assessing, designing, implementing, and continuously improving enterprise Quality Management System (QMS) processes governing Supplier Controls and Sourced Device & Material Controls.

This role supports implementation of evolving global regulatory requirements for software, cybersecurity, Artificial Intelligence (AI), digital health, Software as a Medical Device (SaMD), Sourced Finished Medical Devices (SFMD), medical device components, and other outsourced products and services

The Technical Process Lead will serve as the dedicated lead for supplier-related QMS process enhancements across multiple enterprise initiatives, ensuring consistent implementation of Supplier Controls and Sourced Device & Material Controls that support emerging digital technologies and evolving global regulatory expectations.

Key Responsibilities

• Lead the assessment, design, implementation, and continuous improvement of Supplier Controls and Sourced Device & Material Controls processes supporting technology suppliers, Sourced Finished Medical Devices (SFMD), medical device component suppliers, OEMs, Contract Manufacturers, and other outsourced providers
• Drive cross-functional implementation by facilitating workshops, coordinating stakeholders, managing action items, resolving issues, and ensuring supplier quality initiatives progress according to project objectives and timelines
• Assess and enhance supplier assessment and supplied device/material qualification processes, supplier lifecycle management, supplier change management, supplier remediation, supplier risk management, and the Supplier Change Impact Assessment (SCIA) process, ensuring supplier controls appropriately address software, cybersecurity, AI-enabled technologies, cloud services, digital health, and evolving regulatory expectations
• Develop, revise, and implement QMS procedures, work instructions, templates, forms, quality records, and supporting documentation to establish sustainable, inspection-ready supplier quality processes.

Required Qualifications

• Bachelor's degree in Engineering, Quality, Computer Science, Cybersecurity, Software Engineering, Information Systems, Life Sciences, or a related technical discipline
• Seven (7) or more years of experience in Quality Systems, Supplier Quality, Supplier Controls, Sourced Device & Material Controls, Regulatory Compliance, or related quality functions within a regulated industry.
• Demonstrated experience assessing, designing, implementing, and improving QMS processes, including supplier assessments, supplier controls, supplier documentation, quality agreements, responsibility allocation matrices, and outsourced process controls