Senior Quality Engineer - Medical Devices

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

Senior Quality Engineer – Medical Devices

About the Role

We are seeking an experienced and motivated Senior Quality Engineer to join our team and play a key role in driving quality excellence across medical device product development and manufacturing.

This is an opportunity to work cross-functionally with Engineering, Operations, Project Management, Regulatory and customer teams to support new product introduction (NPI), design quality, validation and continuous improvement initiatives.

You will contribute to maintaining and enhancing our Quality Management System (QMS), ensuring compliance with applicable regulatory requirements and supporting the delivery of safe, effective and high-quality medical devices.

We are looking for a proactive problem-solver who can take ownership of quality activities, influence stakeholders and help drive continuous improvement across the business.

Key Responsibilities

Quality Systems and Regulatory Compliance

• Maintain and continuously improve the Quality Management System in accordance with applicable ISO standards, FDA requirements and relevant medical device regulations.

• Support management reviews, internal audits, supplier audits, customer audits and regulatory inspections.

• Drive and support CAPA, non-conformance investigations, change control, risk management and document control activities.

• Promote a culture of quality, compliance and continuous improvement across the organisation.

Design Quality, NPI and Validation

• Provide quality engineering support throughout new product introduction, design transfer and product release activities.

• Support the implementation and improvement of NPI processes and Lean Product Development practices.

• Develop and review test strategies, protocols, reports and verification and validation (V&V) documentation.

• Support design controls, risk assessments and product lifecycle change management.

• Support validation activities, including sterilisation, packaging, biocompatibility and manufacturing process validation, as applicable.

• Ensure quality requirements are appropriately addressed throughout product development and manufacturing.

Continuous Improvement and Team Collaboration

• Identify opportunities to improve product quality, process effectiveness and QMS performance.

• Work closely with project teams and customers to resolve quality issues and deliver projects that meet or exceed expectations.

• Apply structured problem-solving and risk-based approaches to investigate issues and implement effective corrective and preventive actions.

• Provide technical guidance, coaching and mentoring to engineers and technicians.

• Collaborate with cross-functional teams to support successful product launches, process improvements and manufacturing release activities.

Essential Requirements

• Primary degree in Science, Engineering or another relevant technical discipline.

• Minimum five years' experience in the medical device industry, ideally in quality engineering or a related technical role.

• Demonstrated experience in establishing, maintaining or improving a Quality Management System.

• Strong knowledge of CAPA, risk management, change control and document control systems.

• Understanding of applicable medical device quality standards and regulatory requirements, including relevant ISO standards and FDA requirements.

• Experience investigating quality issues and implementing effective corrective actions.

• Strong analytical, problem-solving, communication and organisational skills.

• Ability to work independently, manage competing priorities and collaborate effectively with cross-functional teams.

• Confidence communicating with stakeholders at different levels of the organisation.

Desirable Experience

• Experience supporting NPI, design controls, design transfer and product release.

• Knowledge of Lean Product Development and continuous improvement methodologies.

• Experience with cleanroom management, sterilisation validation, packaging validation, biocompatibility or process validation.

• Experience developing and executing verification and validation protocols and reports.

• Experience supporting customer, supplier and regulatory audits.

• Experience mentoring colleagues, coordinating projects or leading quality improvement initiatives.

What We Offer

• Company pension.

• Private medical insurance.

• Bike to Work scheme.

• EAP

• Company events.

• On-site parking.

• Sick pay.

Job Type:Full-time