Title: QA Engineer / Senior QA Engineer
Our growing medical device company client is looking to hire a QA Engineer/Senior 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.
- Working as a 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.
- Manage product verification and validation, including risk management, biocompatibility testing (ISO 10993), microbiological (disinfection) validation and clinical evaluation.
- Manage 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.
- Ensure product quality requirements are met both internally and throughout the supply chain during product manufacturing.
- Manage quality related activities for device manufacturing, ensuring controls are implemented and maintained (inspection standards, plans, frequencies, and test methods).
- Manage 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
- Ensuring adherence to all organisational and external regulatory requirements.
- Manage training for company employees in relevant areas of the Quality System
- Manage Quality System audit processes, including supplier evaluations and audits
- Preparation and maintenance of documentation in compliance with the appropriate regulatory requirements
- Ensure interactions with colleagues/stakeholders fully reflects the company values
- Degree or master's degree in science or engineering, or related disciplines
- Minimum of five (5) years of related experience in medical device Quality or Design Assurance
- Class III implantable medical device product development experience preferred.
- Detailed knowledge of and ability to implement medical device quality systems for product design, risk management and product manufacture in line with specified requirements ISO 13485, MDSAP, FDA 21 CFR 820.
- Experience of terminal sterilisation processes, validations, and testing, preferably Ethylene Oxide sterilisation.
- Certified lead auditor preferred.
- Experience of statistics and a good working knowledge of test method validation
- Ability to critically assess data to make quality and patient focused risk-based decisions.
- Experience of preparing technical documentation to support of regulatory submissions.
- Excellent communication, organisational and time management skills
- Availability to travel is required.
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