Key Responsibilities

Quality Operations Support

• Provide day?to?day quality engineering support to manufacturing and operations teams.
• Lead investigations, root?cause analysis, and implementation of corrective & preventive actions (CAPA).
• Support incoming inspection, in?process quality checks, and final product release activities.
• Maintain and improve production documentation, including procedures, work instructions, and inspection plans.

Regulatory & Compliance

• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, MDR, and other relevant standards.
• Lead internal audits and support external audits by notified bodies and regulatory authorities.
• Maintain risk management documentation (e.g., PFMEA, DFMEA, hazard analyses).
• Support change control, deviation management, and quality?system improvements.

Manufacturing & Process Support

• Partner with Engineering and Operations to drive process validation (IQ/OQ/PQ) and equipment qualification.
• Lead quality oversight for new product introduction, scale?up, and continuous improvement projects.
• Monitor and trend key quality and process KPIs, identifying opportunities for operational improvements.
• Lead supplier quality activities, including qualifications, audits, and material performance investigations.

Collaboration & Cross?Functional Leadership

• Work closely with R&D during design transfer to ensure smooth transition into manufacturing.
• Provide quality guidance to manufacturing technicians and engineers.
• Support documentation creation for technical files and regulatory submissions.
• Represent the Quality function in cross?functional meetings and project reviews.

Qualifications & Experience

• Bachelor's or Master's degree in Engineering, Quality, Biomedical, Mechanical, or a related discipline.
• 5 years experience in Quality Engineering, ideally within the medical device or other regulated industry.
• Strong understanding of ISO 13485, FDA 21 CFR 820, and risk?management frameworks.
• Experience in operations?focused quality engineering, including CAPA, non?conformance management, validation, and supplier quality.
• Demonstrated experience supporting manufacturing scale?up in a fast?paced environment.
• Excellent analytical, communication, and problem?solving skills.
• Ability to lead investigations, influence cross?functional teams, and drive improvements independently.

What We Offer

• Opportunity to join an innovative, rapidly growing organisation developing life?changing technology.
• A collaborative and mission?driven work environment.
• Career progression and the chance to shape quality systems at a pivotal stage of growth.
• Competitive compensation and a comprehensive benefits package.

At Wallace Myers International Recruitment Agency we specialise in sourcing professionals for key industries and services. See our website for more details.

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