Senior Quality Engineer

CREGG are hiring for a Senior Quality Engineer to join a leading medical device company in Limerick.

Contact Mark: 086 190 1346 or [email protected] for more information

Senior Quality Engineer – Role Overview
This position is responsible for applying quality engineering expertise and established methodologies to support regulatory compliance and adherence to company quality systems. The role focuses on improving product development, manufacturing operations (both internal and external), and product distribution processes to drive efficiency, quality, and compliance.

Key Responsibilities

Lead investigations into complex product quality and compliance issues across manufacturing operations, including corrective and preventive actions (CAPA), non-conformance investigations, and audit findings, ensuring issues are resolved before product release.
Evaluate manufacturing and R&D processes using continuous improvement methodologies such as Lean and Six Sigma to enhance efficiency, improve manufacturability, and reduce operational risks.
Identify and implement improvements to equipment, tooling, fixtures, and production processes to support process optimization and risk reduction.
Create, review, and maintain risk management documentation, ensuring technical accuracy and compliance with quality standards.
Develop and update production documentation, including work instructions and training materials, to support effective process transfer and operational consistency.
Provide technical direction to technicians, including assigning tasks, overseeing testing activities, and delivering training and performance feedback.
Support the development of junior team members by providing guidance on standard procedures and best practices.
Carry out additional duties as required to support business and operational needs.

Qualifications & Experience

Bachelor’s degree (or equivalent qualification) in Engineering, Science, or a related technical discipline.
Minimum of 4 years’ relevant industry experience, or a combination of industry and academic experience in a related field.

Preferred Skills & Competencies

Strong proficiency in Microsoft Office applications; familiarity with CAD tools is an advantage.
Excellent written and verbal communication skills, with the ability to build effective working relationships and influence stakeholders.
Knowledge of statistical analysis and its practical application in engineering and manufacturing environments.
Hands-on experience working with laboratory or industrial manufacturing equipment.
Solid understanding of engineering fundamentals, principles, and technical problem-solving methodologies.
Strong analytical, organizational, and critical thinking capabilities with a focus on root cause analysis and continuous improvement.
Good understanding of manufacturing processes, systems, and equipment relevant to the assigned area.
Demonstrated ability to lead initiatives and support process improvements.
Working knowledge of quality management systems and compliance requirements.
High attention to detail and commitment to maintaining quality standards.
Ability to collaborate effectively across multiple departments and cross-functional teams.
Comfortable managing multiple priorities and deadlines in a dynamic, fast-paced environment.
Ability to engage with senior stakeholders and external partners on important technical or project-related matters.
Commitment to workplace safety, environmental compliance, and company policies, including health and safety protocols.