Position: Quality Systems Engineer

Reporting to: Quality Systems Manager

Join a team that is passionate about improving healthcare outcomes and ensuring the highest standards in medical device manufacturing. This exciting opportunity as a Quality Systems Engineer with a leading organisation offers the chance to work in a collaborative, innovative environment while enjoying the vibrant community and exceptional quality of life in Limerick City, Ireland.

Key Responsibilities

Internal Audit System Management

Maintain and oversee the Internal Audit System as a lead Quality Auditor, supported by a team of internal auditors.

Conduct comprehensive internal audits across all aspects of the Quality Management System (QMS) to ensure compliance with relevant regulations.

Regulatory and Corporate Audit Support

Organise and manage site preparations for Regulatory and Corporate Audits.

Host audits and manage backroom operations to ensure smooth execution.

Standards and Regulatory Compliance

Manage the standards process, ensuring timely assessment and compliance with evolving regulatory requirements.

Assess regulatory intelligence and implement necessary QMS updates to maintain compliance.

Act as the Subject Matter Expert (SME) for Global Good Documentation Practices (GDP) and lead updates within the QMS.

Process Improvement and Validation

Lead QMS software validation projects and drive assigned process improvement initiatives.

Identify and implement opportunities for improvement proactively.

Supplier Audits

Conduct supplier audits to ensure alignment with the organisation’s stringent quality standards.

Documentation and Training

Prepare, implement, and analyse key Quality Systems documentation.

Deliver training on the Quality Manual and critical Quality Systems procedures.

Quality Assurance Support

Progress and lead Corrective and Preventive Actions (CAPAs) within Quality Assurance.

Provide support to the CAPA programme and ensure meaningful quality measurement.

Prepare and present Management Review documentation.

Leadership and Mentorship

Mentor team members to support their development and successful completion of activities.

Ensure prioritisation and timely resolution of internal or external quality issues.

Provide inputs to KPIs and Management Review while adhering to the organisation’s Code of Conduct.

Qualifications and Requirements

A third-level qualification in Science, Engineering, or a related technical discipline.

A minimum of 6 years of experience with ISO13485, ISO14971, the EU Medical Device Regulation 2017/745, FDA QSR (21 CFR Part 820 and Part 11), ideally within the medical device industry.

Qualified and experienced Lead Auditor, preferably in the Medical Device sector.

Exceptional interpersonal and communication skills, with the confidence to challenge opinions and ensure compliance.

High attention to detail, excellent organisational skills, and proven problem-solving capabilities.

Proficiency in Microsoft Office.

Willingness and ability to travel for company business.

Why Join Us?

Located on the accessible outskirts of Limerick City, Ireland, this organisation offers an opportunity to work at the forefront of medical device innovation. Enjoy a dynamic work culture while living in a city known for its rich history, welcoming community, and excellent quality of life.

This is more than a job—it’s a chance to make a real impact in a company dedicated to improving lives worldwide. If you’re a detail-oriented, self-motivated professional with a passion for quality systems, apply today to join the team!

“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 0868395533 or email stem@hero.ie

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

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

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.”