Quality Lead – Pharma/Medical Device

About the role

We are seeking an experienced Quality Lead to head the Quality team at our Roscommon facility. The role will drive compliance with ISO 13485, FDA 21 CFR and EU MDR requirements, acting as the Management Representative for regulatory authorities.

Key responsibilities

• Define and monitor Quality objectives aligned with site strategy.
• Implement, maintain and continuously improve the Quality Management System to ensure audit readiness.
• Lead internal audits, document control, change management, validation, CAPA, deviation and non‑conformance handling.
• Oversee supplier qualification, risk management, complaint handling, vigilance and post‑market surveillance activities.
• Manage incoming, in‑process and release inspections, as well as packaging, labeling and IFU compliance.
• Conduct regulatory inspections as Management Representative and prepare Management Review meetings.
• Lead cross‑functional quality projects and global compliance initiatives.
• Develop and track site quality metrics and KPIs.

Required profile

• Level 8 degree in a scientific or quality discipline.
• 15–18 years of experience in pharmaceutical or medical‑device manufacturing.
• Proven leadership experience in a regulated environment.

Required skills

• In‑depth knowledge of ISO 13485, FDA 21 CFR and EU MDR 745/2017.
• Internal audit and document control expertise.
• Change management, validation and CAPA processes.
• Risk management, supplier management and complaint handling.
• Vigilance, post‑market surveillance and regulatory inspection experience.