Quality Engineer II
- Galway
- Permanent
- Full-time
- Maintain the Quality Management System (QMS) to ensure compliance with ISO 13485 and other relevant standards, continuously improving QMS documentation and processes.
- Conduct product and process audits to ensure adherence to quality standards, regulatory requirements, and internal procedures, identifying areas for improvement.
- Identify and resolve quality issues, collaborating with production, engineering, and other teams to implement corrective and preventive actions (CAPAs) to improve process efficiency.
- Review and approve documentation such as device history records (DHRs), validation protocols, and change control records, ensuring accuracy and regulatory compliance.
- Lead investigations for non-conformances, performing root cause analysis and implementing corrective actions to drive continuous improvement.
- Conduct risk assessments for new and existing products, supporting risk management strategies in accordance with applicable standards.
- Participate in supplier quality management, ensuring suppliers meet quality standards and conducting audits as needed.
- Provide training and support to production, engineering, and other teams on quality standards, regulatory requirements, and best practices.
- Monitor and report on key quality metrics, updating management on quality performance and areas for improvement.
- Support product development projects, ensuring quality considerations are integrated throughout the product lifecycle.
- Assist in preparation for regulatory inspections and audits, ensuring the company is always prepared for compliance evaluations.
- Bachelor's degree in Engineering, Quality Management, or a related field.
- 3+ years of experience in a Quality Engineer role within a regulated industry.
- Experience working with Quality Management Systems (QMS) and standards such as ISO 13485 and FDA regulations.
- Strong understanding of quality control principles, statistical analysis, and root cause analysis techniques.
- Experience in conducting internal and supplier audits.
- Ability to lead and implement corrective and preventive actions (CAPAs).
- Knowledge of risk management principles and methodologies.
- Excellent documentation and communication skills.
- Ability to work effectively in a cross-functional team environment.