CroiValve is looking to hire a QA/DA 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 role is based on site in our Dublin office.
Reporting Lines
Reports directly to the QA Manager
Key Responsibilities and Duties
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 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.
Support quality related activities for device manufacturing ensuring controls are implemented and maintained (inspection standards, plans, frequencies and test methods).
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
Ensuring adherence to all organisational and external regulatory requirements.
Support training for company employees in relevant areas of the Quality System
Support 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
One Team: working together to ensure the whole is greater than the sum of the parts
Personal Ownership: deliver on commitments
Open Communication: Honest open‑minded communication
Fun: celebrate the successes
Continuous Learning: at an individual and company level
Solution Orientated: Identify problems but focus your energy on solutions
Quality Focused: patient safety comes first
Technical: Fundamental understanding and frequent application of quality principles for medical devices, ideally class III implantable devices. Knowledge of key Quality Management System and manufacturing processes.
Problem Solving: Supports a culture of data‑driven problem solving that ensures development of high‑quality devices. This includes adherence to any systems / processes for robust data capture, analysis and presentation of information to guide the decision‑making process.
Project Management: Demonstrates project management & organisational skills. Ability to complete individual tasks on time and on budget. Able to effectively plan own work when provided outline assignments. Effectively communicates budget needs for quality activities.
Initiative: Demonstrated ability to take initiative to prioritise work, reach business objectives and challenge task team decisions as required.
People Skills: Demonstrates people skills to work effectively with others to achieve company goals.
Communication: Effective verbal and written technical communication skills of technical information. Demonstrated effective presentation and group communication skills
Education and Experience
Degree or master’s degree in science or engineering, or related disciplines
Experience in medical device Quality or Design Assurance is beneficial
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
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