Associate Quality Engineer Galway

Posted: 5th February, 2025

Title: Associate Quality Engineer

Department: Quality

Location: Galway, Ireland

 

Purpose

The Associate Quality Engineer plays a pivotal role in maintaining and enhancing the organisation’s Quality Management System (QMS) in compliance with ISO 13485 and related regulatory standards. The role ensures the effective implementation of quality processes, supports internal and external audits and drives continuous improvement initiatives. By managing document control, training, and risk management activities, the Associate Quality Engineer fosters a culture of compliance and quality excellence, ensuring the organisation consistently meets regulatory requirements, customer expectations, and product safety.

Responsibilities

• Support the implementation, maintenance, and continuous improvement of the QMS to ensure compliance with ISO 13485 standards.
• Perform regular QMS audits and participate in external audits to ensure adherence to regulatory requirements.
• Identify non-conformities, support root cause analysis, and drive corrective and preventive actions (CAPA).
• Maintain the document control system, ensuring timely review, approval, and distribution of quality documents.
• Ensure document changes are correctly implemented and version-controlled in accordance with company procedures.
• Assist in creating, revising, and controlling quality manuals, procedures, work instructions, and forms.
• Prepare reports and track findings through closure, ensuring corrective actions are effectively implemented.
• Assist in developing and delivering training programs related to quality system processes and regulatory compliance.
• Provide day-to-day support to staff on QMS processes and requirements.
• Assist with supplier qualification and monitoring processes, including supplier audits and performance evaluations.
• Ensure supplier documentation complies with regulatory and company standards.
• Respond to customer queries and provide documentation to support regulatory or quality-related requests.
• Participate in risk management activities, including Failure Mode and Effects Analysis (FMEA) and risk assessments.
• Monitor, document, and resolve non-conformances, deviations, and complaints.
• Track CAPA implementation to ensure timely and effective resolution.

The successful candidate will possess the following education & key attributes:

• Bachelor’s degree or diploma in a related field (e.g., Quality Assurance, Engineering, or Life Sciences).
• Six Sigma Green Belt preferable
• Certified Internal Auditor for ISO 13485 or similar qualification.
• Familiarity with risk management standards (e.g., ISO 14971)
• Proven experience in a quality role within an ISO 13485-regulated environment.
• Strong understanding of quality system regulations (e.g., ISO 13485, FDA 21 CFR Part 820).
• Proficiency in quality tools and techniques, such as CAPA, FMEA, and root cause analysis.
• Quality Awareness
• Customer Focus
• Open & Honest Communication
• Team Orientated
• Accountability
• Great Interpersonal and organizational skills

The above list of job responsibilities is not exclusive or exhaustive and the post holder will be required to undertake such tasks as may reasonably be expected within the scope of the post.

FOR INTERESTED APPLICANTS: If you are interested in this position, please send a brief cover letter, resume, please state the job title applying for and any other relevant material for the candidacy to GalwayHR@nelipak.com. Thank you!

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