Quality Systems Lead — Medical Devices & IVD (Ireland)

BD; Limerick; On-site; EUR 76,000 - 116,000; Full time

Job summary

BD is recruiting for a Quality Systems Lead at its Ireland Design Center in Limerick. You will own and enhance the site's QMS, ensuring alignment with global standards and regulatory requirements across development and operations.

You will collaborate with Engineering, Regulatory Affairs, R&D, and facilities to support design controls, risk management, and audit readiness, driving ongoing compliance and continuous improvement.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a technical discipline.
• 8+ years of experience in a regulated medical devices, diagnostics, pharmaceutical, or biologics environment.
• Strong knowledge of FDA QMSR/21 CFR 820, ISO 13485, ISO 14971, IVDR, and product development quality requirements.
• Proven experience with 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 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.

Job description

BD is recruiting for a Quality Systems Lead at its Ireland Design Center in Limerick. You will own and enhance the site's QMS, ensuring alignment with global standards and regulatory requirements across development and operations.

You will collaborate with Engineering, Regulatory Affairs, R&D, and facilities to support design controls, risk management, and audit readiness, driving ongoing compliance and continuous improvement.