Quality Systems Lead - MedTech Compliance & QMS

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

Job summary

Waters Ireland Design Center is seeking a Quality Systems Lead to drive the site’s Quality Management System and align development activities with global regulatory standards. You will collaborate with Engineering, Regulatory Affairs, and R&D to ensure compliant processes across design controls, risk management, and change control.

The role demands at least 8 years in a regulated field, strong knowledge of FDA QMSR/21CFR820, ISO13485, IVDR, and hands-on experience with electronic QMS tools.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or another technical discipline.
• At least 8 years of experience in a regulated industry such as medical devices, diagnostics, pharmaceuticals, or biologics.
• Strong knowledge of FDA QMSR/21CFR820, ISO13485, ISO14971, IVDR, and product development quality requirements.
• Proven experience supporting Design Controls, CAPA, change control, audit management, risk management, and regulatory inspections.
• Ability to influence, build effective working relationships, and make sound decisions in complex environments.
• Experience using electronic quality management systems such as TrackWise, Veeva, AgilePLM, SAP, or Windchill, combined with strong communication, problem-solving, and project management skills.

Responsibilities

• Lead the implementation, maintenance, and continuous improvement of the site’s Quality Management System.
• Ensure compliance with FDA QMSR/21CFR820, ISO13485, ISO14971, IVDR, and other applicable regulatory requirements.
• Act as the primary quality partner for Engineering, Regulatory Affairs, Research & Development, and facility management teams.
• Support Design Verification, Design Validation, and Risk Management activities throughout the product development lifecycle.
• Manage key quality processes, including document control, training, change control, CAPA, audit management, and compliance assessments.
• Coordinate and support external audits, inspections, and regulatory reviews.
• Monitor QMS effectiveness through quality metrics, management reviews, and performance assessments.
• Deliver quality training and promote a culture of compliance, continuous improvement, and accountability.

Skills

Quality management

Regulatory compliance

Cross-functional collaboration

Auditing

Project management

Education

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

Tools

TrackWise

Veeva

AgilePLM

SAP

Windchill

Job description

Waters Ireland Design Center is seeking a Quality Systems Lead to drive the site’s Quality Management System and align development activities with global regulatory standards. You will collaborate with Engineering, Regulatory Affairs, and R&D to ensure compliant processes across design controls, risk management, and change control.

The role demands at least 8 years in a regulated field, strong knowledge of FDA QMSR/21CFR820, ISO13485, IVDR, and hands-on experience with electronic QMS tools.