Quality Systems Lead - Medical Devices QMS Expert

BD; Limerick; On-site; EUR 85,000 - 90,000; Full time

Job summary

Waters Ireland Design Center is hiring a Quality Systems Lead to support medical device and IVD development while partnering with U.S.-based teams. You will be the site QMS expert, driving compliance, continuous improvement, and quality excellence across development and operations.

You will partner with Engineering, Regulatory Affairs, R&D, and facilities to support Design Controls, CAPA, audits, and change control.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a technical discipline.
• 8+ years of experience in a regulated industry (medical devices, diagnostics, pharma, or biologics).
• Strong knowledge of FDA QMSR/21 CFR 820, ISO 13485, ISO 14971, IVDR and product development quality requirements.
• Proven experience supporting Design Controls, CAPA, change control, audit management, risk management, and regulatory inspections.

Responsibilities

• Lead the implementation, maintenance, and continuous improvement of the site's Quality Management System.
• Ensure compliance with FDA QMSR/21 CFR 820, ISO 13485, ISO 14971, IVDR and other regulatory requirements.
• Act as the primary quality partner for Engineering, Regulatory Affairs, R&D, and facilities.
• Support Design Verification, Design Validation, and Risk Management across the product lifecycle.
• Manage document control, training, change control, CAPA, audits, and compliance assessments.
• Coordinate and support external audits, inspections, and regulatory reviews.
• Monitor QMS effectiveness through metrics and management reviews.
• Deliver quality training and promote a culture of compliance and continuous improvement.

Skills

Influence & relationship building

Decision making in complex env.

Communication

Problem solving

Project management

Education

Bachelor's degree in Engineering, Life Sciences, or technical discipline

Tools

TrackWise

Veeva

Agile PLM

SAP

Windchill

Job description

Waters Ireland Design Center is hiring a Quality Systems Lead to support medical device and IVD development while partnering with U.S.-based teams. You will be the site QMS expert, driving compliance, continuous improvement, and quality excellence across development and operations.

You will partner with Engineering, Regulatory Affairs, R&D, and facilities to support Design Controls, CAPA, audits, and change control.