Exciting opportunity to lead Quality Systems compliance in a global medical device company.
Our client, a Global medical device manufacturer based in Galway City is seeking a Quality Systems Engineer to drive the enhancement and compliance of their Quality Management System (QMS) in alignment with US FDA QSMR and ISO 13485 regulations.
This is a career-defining opportunity for a quality professional to take ownership of a transformational project, working within a strong and tenured Quality function.
As a new position it requires external expertise in the area of FDA QSMR.
Role Overview The Quality Systems Engineer will initially lead a QMS transformation project, ensuring compliance with US FDA QSMR and other regulatory requirements.
Following the projects completion (expected 18-24 months), the successful candidate will transition into a Quality Systems management role, maintaining and continuously improving QA processes and regulatory compliance.
Key Responsibilities Lead the development and enhancement of the companys QMS to ensure full compliance with FDA QSMR and ISO 13485.
Conduct gap assessments, identifying areas for improvement and implementing best-in-class quality practices.
Develop, write, and revise quality procedures and processes to meet regulatory and operational requirements.
Engage with stakeholders across the business to gain buy-in and ensure seamless implementation of new quality systems.
Monitor and report on project progress, delivering monthly updates to senior management.
Support and lead third-party audits, including FDA, ISO 13485, and Notified Body inspections.
Drive continuous improvement initiatives, including root cause analysis and CAPA (Corrective and Preventive Actions) implementation.
Conduct internal quality audits to ensure compliance with ISO 13485 and Good Manufacturing Practices (GMP).
Post-project responsibilities: Oversee quality systems management, including document control, internal audits, and third-party audit readiness.
Required Experience & Qualifications Minimum 4 years experience in a medical device manufacturing environment within a US FDA-compliant company.
Bachelors degree in Engineering, Science, Quality Management, or related field.
In-depth knowledge of ISO 13485 and US FDA QSMR is essential.
Proven experience in writing and developing quality procedures and documentation.
Strong problem-solving skills, with experience in root cause analysis and CAPA.
Excellent communication and stakeholder engagement skills.
Highly proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Access).
Self-motivated, flexible, and detail-oriented, with a solutions-driven mindset.
This is an outstanding opportunity for a Quality Systems Engineer looking to make a real impact within this established medical device company.
If you have the experience and drive to succeed in this role, we want to hear from you
Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters For further information on this role please contact Lisa Lawlor on or email Check out all our open jobs on our HERO Recruitment website ?
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Skills: Quality Systems Engineering Quality Management Medical Device Quality Assurance