Xstrahl is an industry-leading medical technology company that develops clinical and research systems for cancer. For more than 20 years, Xstrahl has been shaping the development of superficial and orthovoltage therapies for cancer treatment and driving preclinical research. Xstrahl systems are used in more than 700 treatment and research facilities worldwide, providing complete and specialised clinical radiotherapy and research solutions for cancer and dermatology treatment.
Position Overview:
As a Quality Engineer for Xstrahl, this individual will work with the production team to ensure that the parts delivered from suppliers meet the design specifications and quality requirements. This engineer will help production in supplier quality assessments including creating and following up on SCARs. The Engineer will also ensure that the Device History Record (DHR) is up to date for products manufactured. The Quality Engineer will play a key role in ensuring the document control, CAPA, and complaints process is followed effectively.
Key Responsibilities:
Ensure suppliers are meeting the quality standards as specified in supplier quality agreements. Ensure production feedback reports, NCRs, and CAPAs are created for product and process issues found in production. Check that all incoming parts from suppliers meet the design specifications and quality requirements before they are accepted for production. Create SCARs on non-conforming parts/components and follow up with suppliers on SCARs ensuring corrective actions are effective. Review DHRs for their completeness before authorising shipment of products. Create production feedback reports for product or process issues found during production. Manage the customer return process and ensure that the returned parts are dispositioned as per the quality management system requirements. Support the QARA team in the CAPA process, document control process, and complaints process. Qualifications/Experience:
Experience of working in a medical device industry as a quality engineer is required. Working knowledge of ISO 13485 and ISO 14971. Experience working with manufacturing/production in quality control. Knowledge in processes for transition from EU MDD to EU MDR is a plus but not mandatory.
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Position Overview:
As a Quality Engineer for Xstrahl, this individual will work with the production team to ensure that the parts delivered from suppliers meet the design specifications and quality requirements. This engineer will help production in supplier quality assessments including creating and following up on SCARs. The Engineer will also ensure that the Device History Record (DHR) is up to date for products manufactured. The Quality Engineer will play a key role in ensuring the document control, CAPA, and complaints process is followed effectively.
Key Responsibilities:
Ensure suppliers are meeting the quality standards as specified in supplier quality agreements. Ensure production feedback reports, NCRs, and CAPAs are created for product and process issues found in production. Check that all incoming parts from suppliers meet the design specifications and quality requirements before they are accepted for production. Create SCARs on non-conforming parts/components and follow up with suppliers on SCARs ensuring corrective actions are effective. Review DHRs for their completeness before authorising shipment of products. Create production feedback reports for product or process issues found during production. Manage the customer return process and ensure that the returned parts are dispositioned as per the quality management system requirements. Support the QARA team in the CAPA process, document control process, and complaints process. Qualifications/Experience:
Experience of working in a medical device industry as a quality engineer is required. Working knowledge of ISO 13485 and ISO 14971. Experience working with manufacturing/production in quality control. Knowledge in processes for transition from EU MDD to EU MDR is a plus but not mandatory.
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