Senior Quality Engineer

CroíValve; Leinster; On-site; EUR 70,000 - 110,000; Full time

Job summary

CroíValve is seeking a Quality Assurance/Design Assurance professional to support the development of a cutting-edge transcatheter heart repair device. You will work with a cross-functional team in Dublin to drive design, verification, validation, regulatory submissions, and ongoing quality improvements.

The role requires five years of medical device QA experience, familiarity with ISO 13485, MDSAP, FDA regulations, and strong analytical and communication skills.

Qualifications

• Degree or master’s degree in science or engineering
• Minimum of five (5) years of related experience in medical device Quality or Design Assurance
• Experience with Class III implantable medical device development preferred
• Knowledge of ISO 13485, MDSAP, and FDA 21 CFR 820
• Experience with sterilisation processes, validations, preferably Ethylene Oxide
• Certified lead auditor preferred
• Experience in statistics and test method validation
• Ability to critically assess data for risk-based decisions
• Experience preparing regulatory submission documentation
• Excellent communication and organisational skills
• Availability to travel

Responsibilities

• Design and develop a novel transcatheter heart repair device with cross-functional teams
• Ensure patient safety, customer satisfaction, and product quality
• Manage verification/validation activities, risk management, and clinical evaluation
• Develop and validate test methods for product evaluation
• Maintain quality in design, durability, usability, reliability, and manufacturability
• Mitigate design and manufacturing risks in medical devices
• Ensure quality system adherence (ISO 13485) and continuous QMS improvement
• Oversee supplier evaluation and audit processes
• Prepare technical documentation for regulatory submissions
• Provide training on Quality System requirements to employees
• Travel as required

Skills

Problem solving

Project management

Initiative

People skills

Communication

Data analysis

Education

Bachelor's or Master’s in science/engineering

Minimum 5 years in medical device QA/Design Assurance

Tools

Statistical analysis

Regulatory documentation

Test method validation

Job description

The Role

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 in our Dublin office and can be either onsite or hybrid.

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.

• 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:

  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

Detailed understanding of quality principles and processes used in the design, manufacture and testing required to meet the relevant product standards, regulatory requirements, and patient needs. Applies extensive direction to areas under their responsibility. Provides solutions to difficult issues associated with specific projects.

Problem Solving

Supports a culture of data-driven problem solving that ensure development of high-quality devices. Promotes best practice in relation to capturing, analysis and communicating data to feed into quality decision-making across the company.

Project Management

Effective project management skills, including planning, scenario and contingency mapping. Management of activities at a project level, including delegation of discrete work package to more junior engineers. Ensures timelines are met. Effective in identifying and communicating project risks and requirements to mitigate these risks. Contributes through self and others to ensure completion of projects. Effectively generates budget needs for quality by mapping-out the activities and resource requirements.

Initiative

Takes initiative to drive continuous improvement of the quality management system and reach business objectives. Leads discussions to drive team decisions as required.

People Skills

Strong ability to build relationships and resolve people issues that arise. Positively influences team and cross-functional interactions. Mentors junior team members and sets a positive example for the team, encouraging growth of more junior engineering staff.

Communication

Demonstrated ability to communicate effectively with internal and external stakeholders. Strong presentation of technical information to guide the decision-making process.

Education and Experience

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.

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.