Quality System Engineer

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Exciting opportunity to lead Quality Systems compliance in a global medical device company, based in Galway City .

We are looking for a Quality Systems Engineer to drive the enhancement and compliance of the 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 project's 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.

In this role you will:

• Lead the development and enhancement of the company's 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.

Ideally you will have:

• Minimum 4 years' experience in a medical device manufacturing environment within a US FDA-compliant company.
• Bachelor's 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.

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

For further information on this role please contact Regina on 086 0100903 or email jobs@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel."

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionQuality Assurance, Analyst, and Engineering
• IndustriesMedical Equipment Manufacturing and Manufacturing

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