Quality Systems Lead at BD

Compensation

€85,000 – €90,000/yr

Location: Limerick
Type: Full-time
Level: lead/mgmt
Posted: Sep 25, 2026

Description

BD is hiring a Quality Systems Lead for its Ireland Design Center in Limerick to support medical device and in vitro diagnostic product development. The individual contributor will maintain and improve the site's Quality Management System, ensure compliance with FDA QMSR, 21 CFR 820, ISO 13485, ISO 14971, IVDR, and other regulatory requirements, and partner with engineering, regulatory affairs, research and development, and facility management teams. Responsibilities include design verification and validation, risk management, document control, training, change control, CAPA, audit management, quality metrics, and regulatory review support. The role requires at least eight years of regulated-industry experience and offers an annual salary of €85,000 to €90,000, with a broader stated range of €75,900 to €115,725.

Required Skills

QMS
FDA QMSR
ISO 13485
Risk Management
CAPA
Audit Management
Design Controls
TrackWise

Additional Information

Required Previous Experiences: At least 8 years of experience in a regulated industry such as medical devices, diagnostics, pharmaceuticals, or biologics.
Experience supporting design controls, CAPA, change control, audit management, risk management, and regulatory inspections.
Preferred Qualifications: Bachelor's degree in Engineering, Life Sciences, or another technical discipline.
Strong knowledge of FDA QMSR, 21 CFR 820, ISO 13485, ISO 14971, IVDR, and product development quality requirements.
Experience using electronic quality management systems such as TrackWise, Veeva, Agile PLM, SAP, or Windchill, along with communication, problem-solving, and project management skills.