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