QA Engineer

About the Role

CroiValve seeks a QA Engineer to contribute to the development of an innovative structural heart device. This position is located at our Dublin office and reports directly to the QA Manager. The role involves collaboration within a cross-functional team to design, verify, and ensure quality throughout design development, clinical trials, validation, and regulatory approval phases.

Key Responsibilities

• Contribute as part of a multidisciplinary team in designing a novel transcatheter heart repair device tailored to user needs.
• Demonstrate and uphold a commitment to patient safety, customer satisfaction, and high product quality.
• Support activities around product verification and validation, including risk management, biocompatibility testing following ISO 10993, microbiological disinfection validation, and clinical evaluation.
• Assist in developing test methods for product evaluation and validation purposes.
• Ensure the product's design meets quality standards for durability, usability, reliability, functionality, marketability, and manufacturability.
• Mitigate risks associated with design, utilization, and manufacture of medical devices.
• Ensure internal and supply chain compliance with product quality requirements during manufacturing.
• Support quality-related manufacturing processes by implementing control procedures such as inspections, plans, frequencies, and test methods.
• Assist in implementing and maintaining a compliant quality system adhering to ISO 13485, including risk management processes.
• Drive continuous improvements in the Quality Management System to satisfy stakeholder needs.
• Ensure compliance with all organizational and external regulatory requirements.
• Support employee training initiatives linked to relevant Quality System areas.
• Assist with Quality System audits, including supplier evaluations and audits.
• Prepare and maintain documentation consistent with applicable regulatory standards.
• Foster company values through teamwork, ownership, open communication, celebration of success, continuous learning, solution orientation, and a quality-first mindset prioritizing patient safety.

Essential Requirements

• Strong technical understanding and frequent practical application of quality principles pertinent to medical devices, preferably class III implantables.
• Knowledge of essential Quality Management Systems and manufacturing processes.
• Support data-driven problem solving to ensure development of superior device quality, including adherence to robust systems for data capture, analysis, and presentation driving decisions.
• Demonstrated project management and organizational skills with ability to complete tasks within time and budget, planning assignments effectively, and communicating resource needs for quality activities.
• Initiative to prioritize workload, meet business goals, and challenge team decisions when needed.
• Effective interpersonal skills for collaborative work towards company objectives.
• Strong verbal and written technical communication abilities, including presentation and group discussion skills.

Education and Experience

• Degree or master’s degree in science, engineering, or related fields.
• Experience within medical device Quality or Design Assurance is advantageous.
• Preferred experience with class III medical product development.
• Working knowledge of FDA, GMP, QSR, and ISO 13485 standards.
• Previous auditing experience is beneficial.
• Experience with statistical methods and test method validation.
• Competence in preparing technical documentation.
• Excellent communication capabilities.

Additional Information

• Travel availability is required for this role.