Quality Engineer

Collins McNicholas Recruitment & HR Services Group; Athlone; Presencial; EUR 55.000 - 75.000; Tempo integral

Benefícios oferecidos por esta vaga

Pension

22 days annual leave

Resumo da vaga

Collins McNicholas Recruitment & HR Services Group is seeking a Quality Engineer for our medical device manufacturing client in Athlone. The role focuses on ensuring compliance of the QMS and products with FDA 21 CFR Part 820 and ISO 13485, by partnering with stakeholders and guiding quality processes.

The position supports internal processes and external audits to uphold product quality and patient safety through design, manufacture and distribution of medical devices.

Qualificações

• Bachelor’s Degree in a Science, Engineering, or related discipline.

Responsabilidades

• Support QMS compliance with FDA/ISO and other global regulatory requirements.
• Maintain quality system procedures, work instructions, and records.
• Ensure QMS effectiveness via performance monitoring and management reviews.
• Lead and support CAPA processes and root cause investigations.
• Assist with risk management and design controls in quality processes.
• Coordinate internal audits and support regulatory inspections.
• Present quality metrics and trends to senior management.

Conhecimentos

Regulatory compliance

Quality systems

Audits

Data analysis

Formação

Bachelor's Degree in Science or Engineering

Descrição da vaga

We are currently recruiting for a Quality Engineer for ourmedical device manufacturing client based in Athlone. This person will be responsible for ensuring compliance across the Quality Management System (QMS) and products by partnering with stakeholders, in particular providing guidance and support to stakeholders to meet FDA 21 CFR Part 820 and (EN) ISO 13485 (and related standards).

This position supports both internal processes and external audits to uphold product quality and patient safety in the design, manufacture, and distribution of medical devices.

Responsibilities:

• Support the Quality Management System, ensuring ongoing compliance with FDA, ISO, and other global regulatory requirements.
• Maintain quality system procedures, work instructions, and records.
• Ensure QMS effectiveness through performance monitoring, management review, and continuous improvement initiatives.
• Drive quality strategy aligned with company objectives and regulatory expectations.
• Monitor and trend quality system metrics (CAPAs, complaints, audit findings, etc.) and prepare reports for management reviews.
• Assist and lead the Complaint, Non-conformance reporting andCorrective and Preventive Actions (CAPA) processes by supporting root cause investigations, effectiveness checks, and documentation.
• Assist with risk management processes
• Continuously assess the effectiveness of the QMS and ensure processes are improved through collaboration with all departments, reporting via site metrics, KPI’s and Quality Management Review
• Support the Internal Audit program including coordinating audit schedules, conducting audits, reviewing findings, tracking corrective actions, and providing insights and initiatives to drive continuous improvement.
• Support customer, regulatory and notified body inspections.
• Ensure timely and effective remediation of audit and inspection findings.
• Prepare and present Quality metrics and performance trends to senior management.
• Support Quality Management Review meetings and drive accountability for actions.
• Other duties as required to support the growing Quality organisation.
• Building authentic relationships, ensuring cross-functional Quality Systems meetings are held so that Quality Systems can collaborate with all stakeholders of the QMS to drive improvements

Requirements:

• Bachelor’s Degree in a Science, Engineering, or related discipline
• Minimum 3+ years’ experience in the Medical Device industry within Quality Assurance/Quality Systems.
• Prior experience in a Quality role at a manufacturing facility highly desirable.
• Knowledge of ISO 13485 and FDA 21 CFR Part 820 required
• Strong working knowledge of risk management and design control requirements.
• Demonstrated experience supporting audits and regulatory inspections.
• Strong analytical, organisational, and problem-solving skills.
• Excellent written and verbal communication skills, with experience presenting on Quality Metrics
• Pension
• 22 days AL