Design Quality Assurance Engineer II

• Innovative Medical Device Company: Join a leading company specializing in cutting-edge medical devices for interventional cardiology.
• Global Presence: Be part of a company with a strong international footprint, offering opportunities for global collaboration and growth.
• Commitment to Quality: Work in an environment dedicated to patient safety and product quality, maintaining high standards and effective quality systems.

• Support Design Controls: As a Design Quality Assurance Engineer II, you will support the application of Design Controls in projects, initially focusing on a Product Development Process (PDP) project.
• Maintain Design History File: Develop and maintain the PDP Design History File, including design inputs, design outputs, design verification, design validation, usability risk management, and design reviews.
• Ensure Compliance: Ensure all design changes comply with internal and regulatory requirements, supporting quality, compliance, material continuity, and design Value Improvement Projects (VIPs).
• Collaborate with Cross-Functional Teams: Interface with R&D, Regulatory Affairs, Clinical Risk, Medical Safety, and Operations teams to provide technical and quality systems input.
• Problem-Solving and Decision-Making: Draw conclusions and make decisions from test data using excellent analytical and problem-solving abilities.

• Educational Background: NFQ Level 8 qualification in a STEM discipline.
• Industry Experience: Minimum of 3 years' industry experience; Design Assurance experience is an advantage.
• Technical Expertise: Experience in new product development, design control, risk management, design change, and standards compliance (to regulatory requirements) is advantageous.
• Collaboration and Communication: Strong technical capabilities, communication, and collaboration skills, with the ability to adapt and flex across projects.
• Motivation and Enthusiasm: Proven ability to work well both as part of a team and individually, with a strong motivation to develop your career and drive improvements in product and process quality.

• Competitive Salary: Attractive compensation package based on experience and qualifications.
• Career Development: Opportunities for professional growth and career advancement within a dynamic and innovative company.
• Comprehensive Benefits: Including health insurance, retirement plans, and other employee benefits.
• Challenging Work Environment: Work on cutting-edge projects in a supportive and collaborative environment.

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