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