Our client is looking to hire a QA Engineer who will support the product development of a cutting edge structural heart device through design development, verification, clinical trials, validation and regulatory approval. This position offers the opportunity to join an exciting early stage company.
Role and responsibilities:
- Ensuring adherence to all organisational and external regulatory requirements.
- Preparation and maintenance of documentation in compliance with the appropriate regulatory requirements
- Working as a part of a crossfunctional 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 validations.
- 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).
- B.S. 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.
- Experience of statistics and a good working knowledge of test method validation.
- Experience of preparing technical documentation
- Excellent communication, organizational and time management skills
- Availability to travel may be required
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement.
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.