Senior Design Quality Assurance Engineer About Your New Employer 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. About Your New Job Lead Design Quality Projects: As a Senior Design Quality Assurance Engineer, you will lead projects related to the drug-coated balloon product line, ensuring compliance with all internal and regulatory requirements. Supervision and Mentoring: Provide coaching and mentoring support within your reporting structure, including assignment and oversight of small to medium projects within the sustaining organization. Ensure Compliance: Maintain regulatory compliance with appropriate guidance documents such as company SOP/WIs and EU/FDA/Global guidelines. Interface with Cross-Functional Teams: Work closely 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. Support Regulatory Audits: Support internal and external regulatory audits as required. Post Market Surveillance: Provide support and direction for post market surveillance activities, such as Field Signal Evaluations, assessment of field product performance, NCEPs, Periodic Safety Update Reports (PSURs), and Q&A from regulatory authorities. What Skills You Need Educational Background: NFQ Level 8 qualification in a STEM discipline. Industry Experience: Minimum of 6 years industry experience; Design Assurance experience is preferable. Technical Expertise: Experience in design control, risk management, design change, and standards compliance (to regulatory requirements). Leadership Skills: Strong leadership, problem-solving, technical capabilities, communication, and collaboration skills. Team Collaboration: Proven ability to work well both as part of a team and individually. Motivation and Enthusiasm: Enthusiastic and fully motivated to develop your career, demonstrate best practices, and drive improvements in product and process quality. Coaching and Development: Interested in coaching and developing team members. Whats on Offer 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. Whats Next Apply now by clicking the Apply Now" button or call me, (Your Name), on (Your Phone Number). If the job isnt quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC, and Contract jobs available. Skills: FDA regulations CAPA Design Assurance