Quality manager

Site Quality Manager
Role Overview
A new opportunity has opened up for a Quality Manager for a manufacturing site based in Roscommon. The Site Quality Manager will be responsible for leading the Quality Management System (QMS), ensuring compliance with medical device regulations and quality standards, and driving a proactive quality culture. The role oversees quality operations, regulatory inspections, product quality, sterility assurance, complaint investigations, and continuous improvement initiatives to support safe and compliant product manufacturing, overseeing a team of 10.
Key Responsibilities

Lead, maintain, and continuously improve the site Quality Management System (QMS).
Ensure compliance with ISO 13485, FDA QMSR (21 CFR Part 820), EU MDR 2017/745, and other applicable regulatory requirements.
Set and monitor site quality objectives, KPIs, and compliance metrics.
Manage key quality processes including CAPA, audits, supplier quality, risk management, deviations, change control, validation, complaints, and document control.
Act as the site representative during regulatory inspections, audits, and authority interactions.
Oversee product release, incoming and in-process quality controls, and supplier quality activities.
Lead complaint handling, root cause investigations, corrective actions, and vigilance reporting.
Ensure effective sterility assurance, contamination control, environmental monitoring, and validation programs.
Develop and mentor quality teams while promoting a strong "Quality First" culture across the organisation.
Drive quality improvement projects and support business growth while maintaining regulatory compliance.

Requirements & Experience

Degree (Level 8 or higher) in Quality, Science, Engineering, or a related discipline.
ISO 13485 Lead Auditor certification desirable.
15+ years' experience in quality management within a regulated manufacturing environment.
Experience leading a site or business-unit quality function, preferably within sterile medical devices, pharmaceutical, implantable, or injectable product manufacturing.
Strong working knowledge of ISO 13485, FDA QMSR / 21 CFR Part 820, EU MDR, and MDSAP requirements.
Proven experience leading regulatory inspections and audits, including FDA, Notified Body, HPRA, customer, and MDSAP audits.
Demonstrated success in building and maintaining an audit-ready quality culture.
Experience with CAPA, risk management, validation, supplier quality, complaint handling, sterility assurance, and electronic Quality Management Systems (eQMS).
Strong leadership, communication, problem-solving, and stakeholder management skills.

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