Senior Quality Engineer

SIGMAR RECRUITMENT

GALWAY

Senior Quality Engineer. Work with one of the world’s largest diagnostic device developers globally, who are working on ground breaking and highly innovative devices making a huge impact in communities across the world. Their Irish sites have been at the forefront of the growth globally and this position will focus on developing and improving the products by focusing on customer feedback. Responsibilities: Woking within the post market quality team, use your comprehensive knowledge of medical device safety to address complex assessments and customer feedback. Work cross functionally with regulatory and global operations to make informed decisions for product improvement and patient safety. Act as the escalation point for NCRs and CAPAs. Conduct risk assessments to identify core issues and utilize problem solving skills to find resolutions accordingly. Drive continuous improvement from a regulatory, quality and product quality point of view. Maintain and develop the QMS in line with ISO9001, ISO13485 and ISO14971 standards. Use excellent communication, organization and interpersonal skills to achieve project timeline goals and ensure total conformance during audits. Requirements: Bachelor’s degree with 5 years’ experience in the medical device industry, preferable in Post Market Surveillance. Strong knowledge of CE, FDA, PAL, IVDR or MDSAP regulations. To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: jporter@sigmar.ie. All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent. Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

1648 days ago