My client, a global company specialising in the development, manufacture and marketing of clinical diagnostic products are hiring a Principal Design Quality Engineer to join their Continuous Glucose Monitoring Division in Bray Co. Wicklow.
This is an exciting and innovative opportunity for an experienced candidate working with biosensors, the future of medical devices!
About the role
· Continuous Glucose monitoring device is a key pillar of growth for the organisation as they look to enter new markets with an innovative device, providing a more sustainable and accessible alternative to diabetes patients globally.
· To support this innovative products development, they now require a Senior/Principal Design Quality Engineer to develop and implement compliance strategies to support New Product Introductions (NPI) and current marketed products within the areas of design, design transfer, manufacturing, and service.
· As a critical member of the NPI core team you will ensure adherence to the Quality Management System (QMS) and regulatory requirements.
· Employing strong critical thinking and influencing skills you will work cross-functionally to ensure robust Quality decisions.
· In this role, you will have a direct impact on ensuring patient safety, audit readiness and execution and enable commercial delivery of the companies’ systems.
· This role will be responsible for both CGM and our wider product set, however CGM is the primary focus foreseen for this role.
Skills and Education
· Bachelor’s degree in a relevant scientific/ engineering discipline or the ability to show technical understanding of scientific/ engineering principles through industrial experience.
· >10 years substantial expertise in Design Quality Engineering in the Medical Device industry.
· Experience working with regulatory and notified bodies during submissions and external audits.
· Excellent knowledge of design control and risk management processes.
· Understanding of regulatory requirements, e.g. ISO 13485/ FDA regulations.
· Strong knowledge of quality management systems (QMS).
· Proficiency in conducting design reviews.
· Familiarity with industry-specific design standards and best practices.
· Excellent communication, collaboration, and interpersonal skills.
· Continuous learning mindset to stay updated with evolving technologies and industry practices.
For a full Job Spec and to apply for this role please call Katie on +353 1 895 5770 or e-mail [email protected]
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 895 5770
