Quality Engineer – Medical Devices (QMS, CAPA & FDA)

Hero Recruitment; Athlone; On-site; EUR 52,000 - 70,000; Full time

Benefits offered by this job

Health insurance after probation

Career development in medical device

Collaborative environment

High-quality medical device products

Job summary

Hero Recruitment is sourcing a Quality Engineer for our client in Athlone, Co. Westmeath. The role requires 3–4 years of experience within a regulated medical device manufacturing environment and a strong understanding of QMS, FDA requirements and ISO 13485.

You will support maintenance and continuous improvement of the QMS, lead CAPA and change control, participate in audits and collaborate with Manufacturing, Engineering and Regulatory teams to drive quality improvements across processes.

Qualifications

• Bachelor’s or Master’s degree in Science/Manufacturing Engineering with QMS experience.
• 3–4 years of quality engineering/QA in a regulated manufacturing setting.
• Experience in FDA QA requirements and ISO 13485.
• CAPA, NCR, change control, risk management and audits experience.
• Strong problem-solving and cross-functional collaboration.
• Knowledge of medical device industry and sterile/controlled environments.

Responsibilities

• Maintain and improve the QMS in compliance with FDA and ISO 13485.
• Lead root cause analysis, CAPA, NCRs, change control and risk management.
• Investigate NCRs and ensure timely closure with effective corrective actions.
• Support internal and external audits and audit responses.
• Collaborate with Manufacturing and Engineering to resolve issues.
• Review QMS documentation and quality records.
• Support supplier quality activities and supplier-related quality performance.
• Promote quality culture across the organisation.

Skills

Quality systems

Root cause analysis

CAPA

NCRs

Audits

Problem solving

Education

Bachelor’s or Master’s degree in Science/Manufacturing Engineering

Tools

Minitab

Q-Pulse

SPC

Job description

Hero Recruitment is sourcing a Quality Engineer for our client in Athlone, Co. Westmeath. The role requires 3–4 years of experience within a regulated medical device manufacturing environment and a strong understanding of QMS, FDA requirements and ISO 13485.

You will support maintenance and continuous improvement of the QMS, lead CAPA and change control, participate in audits and collaborate with Manufacturing, Engineering and Regulatory teams to drive quality improvements across processes.