Quality Engineer

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

Position Title: Quality Engineer

Location: Athlone, Co. Westmeath

3–4 years experience

Right to Work: Irish/EU Citizen

About the Role

Seeking a motivated and experienced Quality Engineer to join our team in Athlone. This is an excellent opportunity for a Quality Engineer with 3–4 years of experience to develop their career within a highly regulated medical device manufacturing environment. The successful candidate will support the maintenance and continuous improvement of our Quality Management System while working closely with Manufacturing, Engineering, Regulatory and other cross-functional teams. The ideal candidate will have a strong understanding of quality systems, problem-solving methodologies and manufacturing processes, together with practical experience working within an FDA-regulated medical device environment.

Key Responsibilities

• Support the maintenance and continuous improvement of the Quality Management System (QMS) in compliance with FDA requirements, ISO 13485 and applicable standards and regulations.
• 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, corrective actions and timely closure.
• Support CAPA development, implementation and effectiveness monitoring.
• Support internal and external audits, including preparation, audit responses and follow-up actions.
• Collaborate with Manufacturing and Engineering to resolve quality issues and drive continuous process improvement.
• Support product and process risk assessments, process validation, equipment qualification and other quality-related manufacturing activities.
• Review and maintain QMS documentation, including procedures, work instructions, inspection records and related quality records.
• Support supplier quality activities, including supplier issues, corrective actions and quality performance monitoring.
• Support change control for product and process changes, ensuring quality requirements are addressed.
• Analyse quality data and trends to identify improvement opportunities and prevent recurring issues.
• Promote a strong quality and continuous improvement culture across the organisation.

Qualifications & Experience

• Bachelor’s or master’s degree in a Science or Manufacturing-related Engineering discipline, Biomedical Engineering, Quality, Science or a related field. Candidates should have strong practical experience in Medical Device Quality Management Systems (QMS).
• 3–4 years’ experience in a Quality Engineering, Quality Assurance or similar role within a regulated manufacturing environment.
• Previous experience within the medical device industry is highly desirable.
• Practical experience with FDA Quality System requirements is essential.Good understanding and practical application of ISO 13485.
• Experience with CAPA, NCRs, root cause analysis, change control, risk management and audits.
• Strong problem-solving and analytical skills, with the ability to investigate quality issues and identify effective corrective actions.
• Good understanding of manufacturing processes and quality control principles.
• Strong attention to detail and ability to manage multiple quality activities effectively.
• Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.

Good to Have

The following would be considered an advantage but are not essential requirements for the role:

• Knowledge or experience of EU MDR requirements.
• Knowledge of SPC, statistical analysis and quality improvement methodologies.
• Knowledge of process validation and equipment qualification.
• Knowledge or exposure to supplier quality management.
• Knowledge of cleanroom or controlled manufacturing environments.
• Lean Six Sigma or other recognised quality-related qualification.
• Experience using quality and data analysis software such as Minitab, Q-Pulse or equivalent systems.
• Previous experience within the orthopaedic or implant manufacturing sector.

What We Offer

• Health insurance after successful completion of probation
• Career development within the medical device industry
• Collaborative and supportive working environment
• Opportunity to work on high-quality medical device products