Quality Systems Lead – Medical Devices & Regulatory

BD (Becton, Dickinson and Company); Limerick; On-site; EUR 76,000 - 116,000; Full time

Job summary

BD in Ireland invites applications for a Quality Systems Lead at our Ireland Design Center in Castletroy, Limerick. This individual contributor role drives the Quality Management System, aligning with FDA QMSR, ISO, and IVDR standards to support product development and production.

You will partner with Engineering, Regulatory Affairs, R&D, and facilities to advance verification, validation, risk management, and compliance initiatives across development lifecycles.

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/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.
• Ability to influence, build effective working relationships, and make sound decisions in complex environments.
• Experience using electronic quality management systems such as TrackWise, Veeva, Agile PLM, SAP, or Windchill.

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 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

QMS knowledge

Regulatory compliance

Cross-functional collaboration

Quality systems leadership

Education

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

Tools

TrackWise

Veeva

Agile PLM

SAP

Windchill

Job description

BD in Ireland invites applications for a Quality Systems Lead at our Ireland Design Center in Castletroy, Limerick. This individual contributor role drives the Quality Management System, aligning with FDA QMSR, ISO, and IVDR standards to support product development and production.

You will partner with Engineering, Regulatory Affairs, R&D, and facilities to advance verification, validation, risk management, and compliance initiatives across development lifecycles.