Senior Quality Engineer – Medical Devices & NPI Lead

ICS Medical Devices; Galway; On-site; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Company pension

Private medical insurance

Bike to Work scheme

EAP

Company events

On-site parking

Sick pay

Job summary

ICS Medical Devices is seeking a Senior Quality Engineer to drive quality excellence across medical device development and manufacturing. You will support NPI, design quality, validation and continuous improvement initiatives while maintaining a robust QMS in line with ISO and FDA requirements.

The role involves cross-functional collaboration with Engineering, Operations, Regulatory and customers to ensure safe and high-quality devices and successful product launches.

Qualifications

• Minimum five years' experience in the medical device industry, ideally in quality engineering or related technical role.
• Strong knowledge of CAPA, risk management, change control and document control systems.
• Experience establishing and improving a Quality Management System.
• Ability to communicate with stakeholders at different levels of the organisation.

Responsibilities

• Maintain and improve the Quality Management System in line with ISO standards, FDA requirements and medical device regulations.
• Support internal and supplier audits, regulatory inspections and management reviews.
• Drive CAPA, investigations, change control, risk management and document control activities.
• Provide technical guidance and mentoring to engineers and technicians.
• Collaborate with cross-functional teams to support product launches and manufacturing release activities.

Skills

Quality engineering

CAPA

Risk management

Regulatory compliance

Audits

Education

Bachelor's degree in Science or Engineering

Job description

ICS Medical Devices is seeking a Senior Quality Engineer to drive quality excellence across medical device development and manufacturing. You will support NPI, design quality, validation and continuous improvement initiatives while maintaining a robust QMS in line with ISO and FDA requirements.

The role involves cross-functional collaboration with Engineering, Operations, Regulatory and customers to ensure safe and high-quality devices and successful product launches.