.The QA Engineer will support the product development of a cutting edge structural heart device through design development, verification, clinical trials, validation and regulatory approval.
Role and responsibilities:
- Working as part of a cross-functional team to design and develop a novel transcatheter heart repair device in line with user needs
- Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality.
- Support product verification and validation, including risk management, bio-compatibility testing (ISO 10993), microbiological (disinfection) validation and clinical evaluation
- Support development of test methods for product evaluation and validation, including validatiions
- Ensure quality in the product's design for durability, usability, reliability, functionality, marketability, and manufacturability
- Mitigating risks associated with the design, use and manufacture of Medical devices.
- Support implementation and maintenance of a robust and fully compliant quality system in accordance with ISO 13485, including risk management
- Continuous improvement of the QMS to meet the requirements of all stakeholders
- Ensure product quality requirements are met both internally and throughout the supply chain during product manufacturing.
- Support quality related activities for device manufacturing ensuring controls are implemented and maintained (inspection standards, plans, frequencies and test methods).
- Ensuring adherence to all organisational and external regulatory requirements.
- Preparation and maintenance of documentation in compliance with the appropriate regulatory requirements
- Degree or masters degree in science or engineering, or related disciplines
- Minimum of three (3) years of related experience in medical device Quality or Design Assurance
- Class III medical product development experience preferred
- Working knowledge of FDA, GMP, QSR and ISO 13485 requirements.
- Previous auditing experience preferred.
- Experience of statistics and a good working knowledge of test method validation.
- Experience of preparing technical documentation
- Excellent communication, organisational and time management skills
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.