QA Engineer

CroíValve; Leinster; On-site; EUR 60,000 - 90,000; Full time

Job summary

CroiValve is hiring a QA/DA Engineer to support the development of a cutting-edge transcatheter heart repair device in Dublin. You will work within a cross-functional team to ensure design development, verification, and regulatory readiness.

The role focuses on risk management, validation activities, and building a robust quality system in line with ISO 13485. Availability to travel may be required and the candidate should have experience with medical device QA/DA.

Qualifications

• Experience in medical device QA/DA is beneficial.
• Knowledge of key Quality Management System requirements and manufacturing processes.
• Ability to analyze data and support decision-making in quality activities.
• Familiarity with regulatory standards (FDA, GMP, QSR, ISO 13485).
• Auditing experience and technical documentation preparation.

Responsibilities

• Design and develop a novel transcatheter heart repair device in line with user needs.
• Support verification/validation, risk management, and clinical evaluation activities.
• Develop test methods for product evaluation and validation.
• Ensure design quality for durability, usability, reliability, and manufacturability.
• Maintain and improve the quality system per ISO 13485 and regulatory requirements.
• Support supplier audits and documentation preparation.
• Collaborate with QA Manager and cross-functional teams.

Skills

Quality principles

Medical device QA

Data analysis

Statistical testing

Risk management

Documentation

Auditing

Education

Degree or master’s degree in science or engineering

Experience in medical device QA/DA

FDA, GMP, QSR and ISO 13485 knowledge

Job description

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 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.
• 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:

o One Team: working together to ensure the whole is greater than the sum of the parts

o Personal Ownership: deliver on commitments

o Open Communication: Honest open-minded communication

o Fun: celebrate the successes

o Continuous Learning: at an individual and company level

o Solution Orientated: Identify problems but focus your energy on solutions

o Quality Focused: patient safety comes first

Essential requirements

• 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 ensure 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 prioritize 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
• 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

Availability to travel is required.

The above role profile is not designed to cover a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned from time to time.