Job Title: Quality Engineer
Our client, a leading manufacturer of health and wellness products, is seeking an experienced Quality Engineer to join their European headquarters in County Galway. This role will report directly to the Quality Manager .
Key Responsibilities:
* Implement lean practices in the quality management system (QMS) area.
* Drive system improvement initiatives throughout the facility, reducing waste and increasing efficiency.
* Participate and lead ongoing problem-solving and corrective action teams, leading CAPA and non-conforming product investigations.
* Lead validation activities in both process and software areas.
* Perform internal audits.
* Ensure current and future quality products are compliant with current and proposed QMS & regulatory requirements.
* Support supplier management initiatives and drive improvement in this area.
* Develop the quality system in line with current industry best practices.
* Support third-party regulatory and certification body audits.
* Provide quality support on new product transfers.
* Support the risk management process.
Requirements:
* A qualification in science or engineering with a minimum of 3 years' experience in a quality engineer role is required.
* Must have knowledge and experience in the following standards and regulations: ISO 13485:2016, ISO 14971:2019, ISO 14001:20015.
* Good organization and investigation skills are essential.
* Lean qualification and experience are desirable.
* Lead auditor qualifications are required.
* Excellent communication skills, problem-solving skills, and attention to detail are required.