Objectives / Scope The successful candidate will work within the company’s existing QHSE team to ensure the effective delivery of high-quality products that meet customer requirements and regulatory standards. The candidate is responsible for implementing quality assurance processes, driving continuous improvement, and fostering a culture of quality throughout the business.
Main Responsibilities Assisting with all site quality related processes to ensure the product is compliant with regulatory requirements. Responsible for responding to customer quality requests, completion of customer quality questionnaires. Review any CAPA and non-conformances raised in the IMS and working with owners to ensure adequate root cause analysis has been conducted and any corrections or corrective/preventative actions have been implemented correctly. Working with all department stakeholders to deliver process / procedure improvements. Raise and action vendor non-conformance reports, assisting Supply chain as and when required to mitigate risk. Responsible for the internal audit schedule for the ISO 9001 integrated management system. This includes issuance of the audit schedules, conducting audits, working with support auditors from other departments, reporting any findings and tracking completion of actions and trending of findings. Preparation and assisting with adding customers to the recertification and surveillance audit involvement. Ensuring documentation in the ISO 9001 Integrated Management System is current and controlled. Responsible for the review and approval of process changes to the IMS to ensure all changes to assessed and implemented correctly. Responsible for assisting the Supply Chain function with new suppliers onboarding as well as ongoing evaluation. Assist and participate in internal ISO 9001 related training sessions. Any other task or project as required by the business.
Skills Base Experience of working within a Quality Assurance or Quality Systems function within an ISO 9001 Management System, or similar Experienced internal auditor for ISO 9001 or similar Experience of investigating/reviewing CAPA and an understanding of root cause analysis tools Experienced in QA / QMS activities such as documentation control and change control processes. Experience of responding to customer quality related queries
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