Quality Engineer: FDA-Regulated Manufacturing & QMS

Gi Group (United Kingdom); Athlone; On-site; EUR 45,000 - 55,000; Full time

Job summary

Gi Group (United Kingdom) is seeking a Quality Engineer for Athlone to support the maintenance and continuous improvement of the Quality Management System within a highly regulated manufacturing environment. The role demands 3-4 years of experience and deep knowledge of FDA and ISO 13485 standards, with strong problem-solving and cross-functional collaboration.

The successful candidate will work closely with Manufacturing, Regulatory and Engineering teams to drive quality improvements, audits,

Qualifications

• Bachelor's or Master's degree in Science, Manufacturing Engineering, Biomedical Engineering, Quality or related discipline.
• 3-4 years' experience within Quality Engineering, QA or similar in a regulated environment.
• Experience in a regulated industry, preferably medical device manufacturing.
• Practical experience with FDA Quality System requirements.
• Good understanding and application of ISO 13485.
• Experience with CAPA, NCRs, root cause analysis, change control, risk management and audits.
• Strong problem-solving and analytical skills for investigating quality issues and corrective actions.
• Good understanding of manufacturing processes and quality control principles.
• Attention to detail with ability to manage multiple quality activities.
• Excellent communication and interpersonal skills for cross-functional work.

Responsibilities

• Support maintenance and continuous improvement of the Quality Management System (QMS) in line with FDA requirements, ISO 13485 and applicable standards.
• Lead and support quality activities including root cause analysis, CAPA, NCRs, change control and risk management.
• Investigate Non-Conformance Reports (NCRs) ensuring effective root cause analysis and timely corrective actions.
• Support CAPA development, implementation and effectiveness monitoring.
• Support internal and external audits, including preparation, responses and follow-up actions.
• Collaborate with Manufacturing and Engineering to resolve quality issues and drive improvements.
• Support product and process risk assessments, process validation and equipment qualification.
• Review and maintain QMS documentation including procedures and records.
• Support supplier quality activities and supplier-related quality improvements.
• Assist change control for product and process changes ensuring quality requirements are met.
• Analyze quality data and trends to identify improvements and prevent recurrence.
• Promote a strong quality and continuous improvement culture.

Skills

Quality engineering

Regulatory compliance

Root cause analysis

CAPA management

Change control

Risk management

Auditing

Data analysis

Problem solving

Cross-functional collaboration

Education

Bachelor's or Master's in Science

Manufacturing Engineering

Biomedical Engineering

Quality

Tools

Minitab

Q-Pulse

CAPA tracking tools

Job description

Gi Group (United Kingdom) is seeking a Quality Engineer for Athlone to support the maintenance and continuous improvement of the Quality Management System within a highly regulated manufacturing environment. The role demands 3-4 years of experience and deep knowledge of FDA and ISO 13485 standards, with strong problem-solving and cross-functional collaboration.

The successful candidate will work closely with Manufacturing, Regulatory and Engineering teams to drive quality improvements, audits,