Quality Engineer Role
We are seeking a skilled Quality Engineer to join our European headquarters in County Galway, Ireland. Reporting directly to the Quality Manager, this position will be responsible for ensuring the highest standards of quality throughout our health and wellness product manufacturing facility.
Key Responsibilities:
* Implement lean practices to optimize our Quality Management System (QMS) area, reducing waste and increasing efficiency.
* Drive system improvement initiatives throughout the facility, focusing on process excellence and customer satisfaction.
* Participate in and lead ongoing problem-solving and corrective action teams, investigating CAPA and non-conforming product issues.
* Lead validation activities in both process and software areas, ensuring compliance with industry regulations.
* Perform internal audits to maintain our high standards of quality.
* Ensure that all current and future products meet the requirements of current and proposed QMS & regulatory standards.
* Support supplier management initiatives and drive continuous improvement in this area.
* Develop and implement quality systems aligned with industry best practices.
* Support third-party regulatory and certification body audits, demonstrating our commitment to quality.
* Provide quality support for new product transfers, ensuring seamless integration.
* Contribute to the risk management process, identifying and mitigating potential risks.
Requirements:
* A degree in science or engineering, with at least 3 years' experience in a Quality Engineer role.
* Knowledge and experience in ISO13485:2016, ISO14971:2019, and ISO14001:20015 standards and regulations.
* Strong organizational and investigation skills, with attention to detail and excellent communication skills.
* Lean qualification and experience are desirable.
* Lead auditor qualifications are required.