My client is a global company specialising in the development, manufacture and marketing of clinical diagnostic products. They are hiring a Principal Design Quality Engineer to join their Continuous Glucose Monitoring Division.
This is an exciting opportunity for an experienced candidate working with biosensors, the future of medical devices.
About the Role
* The organisation is entering new markets with an innovative device providing a more sustainable and accessible alternative to diabetes patients globally.
* A Senior/Principal Design Quality Engineer is required 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.
* You will ensure adherence to the Quality Management System (QMS) and regulatory requirements as a critical member of the NPI core team.
* 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 company's systems.
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/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.