Overview
Quality Assurance Manager Jobs in Roscommon, County Roscommon, Ireland at Collins McNicholas Recruitment & HR Services Group
Title: Quality Assurance Manager
Company: Collins McNicholas Recruitment & HR Services Group
Location: Roscommon, County Roscommon, Ireland
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.
For further details about this opportunity, please contact Gillian Nicholson [email protected] 090 6450665
