Job Title: Quality Engineer
Our company, a leading manufacturer of health and wellness products, is seeking a qualified Quality Engineer to join our European headquarters team in Galway. This role will report directly to the Quality Manager.
Responsibilities:
* Implement lean practices in the Quality Management System area to enhance efficiency and reduce waste.
* Drive system improvement initiatives throughout the facility, promoting continuous improvement and increasing productivity.
* Participate in and lead ongoing problem-solving and corrective action teams, conducting CAPA and non-conforming product investigations to identify and address quality issues.
* Lead validation activities for both process and software areas to ensure compliance with regulatory requirements.
* Perform internal audits to verify adherence to quality standards and regulatory requirements.
* Ensure that current and future quality products comply with existing and proposed Quality Management System and regulatory requirements.
* Support supplier management initiatives and drive improvements in this area.
* Develop and maintain the quality system in line with current industry best practices.
* Support third-party regulatory and certification body audits to ensure compliance with external requirements.
* Provide quality support during new product transfers.
* Contribute to risk management processes to identify and mitigate potential quality risks.
Requirements:
* A degree in science or engineering, with a minimum of 3 years' experience in a quality engineer role.
* Knowledge and experience in relevant standards and regulations, including ISO 13485:2016, ISO 14971:2019, and ISO 14001:2004.
* Excellent organizational and investigation skills are essential for success in this role.
* Lean qualification and experience are desirable, as well as lead auditor qualifications.
* Strong communication, problem-solving, and attention-to-detail skills are required for this position.