Quality Engineer
We are seeking a Quality Engineer to join our team at the European headquarters of a well-established manufacturer of health and wellness products located in County Galway.
The successful candidate will report directly to the Quality Manager and be responsible for ensuring the delivery of high-quality products that meet current and proposed regulatory requirements.
Key Responsibilities:
* Implement lean practices in the quality management system (QMS) area to drive efficiency and reduce waste.
* Lead system improvement initiatives throughout the facility to increase productivity and minimize errors.
* Participate in ongoing problem-solving and corrective action teams, leading investigations into non-conforming products and CAPA procedures.
* Oversee validation activities in both process and software areas.
* Perform internal audits to ensure compliance with QMS and regulatory standards.
* Ensure that current and future quality products meet or exceed industry best practices and 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.
* Contribute to risk management processes.
Requirements:
* A degree in science or engineering is required, along with a minimum of three years' experience in a quality engineer role.
* Familiarity with relevant industry standards and regulations, including ISO 13485:2016, ISO14971:2019, and ISO14001:20015.
* Strong organizational and investigation skills are essential.
* A lean qualification and experience are desirable.
* Lead auditor qualifications are required.
* Excellent communication, problem-solving, and attention-to-detail skills are necessary for success in this role.