**Overview** **About Us:** Cordis is an independent, customer-focused global provider of interventional cardiovascular medical technologies. During our 60+ year history we’ve established a legacy of pioneering breakthrough technologies, including the first guiding catheters and coronary drug eluting stents. Cordis has built a strong global footprint that spans over 70 countries. We’re teammates, not just employees. Our culture empowers you to act like an owner and unleash your full potential in the process. With diverse teams on a global scale, we foster an inclusive atmosphere where everyone is embraced for who they are, their unique perspective, and what they bring to the table. We believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients. If you love a challenge and are ready to have a direct, positive impact on the lives of millions, then Cordis is just the place for you. Join us, and let’s improve the wellbeing of millions, together. **We are the people behind the people who keep saving lives.** This position takes the lead in executing tasks intended to drive compliance across all aspects of the quality system, The role will play a key part in supporting the integration of our quality system with any acquired company’s systems and supporting component customer quality activities/processes for component business driving customer quality and understanding customer requirements. This position will collaborate with cross-functional engineering teams to support the change management needed for QMS system integrations, production ramp-up, driving process improvements, and ensuring compliance and driving a culture of quality excellence. The **Sr Quality Engineer** works on problems and projects of moderate scope, using advanced analysis techniques to drive continuous improvement at pace. The position exercises judgment within defined procedures and practices to determine appropriate action and demonstrates full use and application of standard principles, theories, concepts, and techniques. The candidate must be able to accomplish broad and complex assignments and may provide technical guidance to lower-level personnel. **Responsibilities** **Quality System Integration:** Support the integration of the company’s quality system with that of an acquired company, ensuring a seamless transition and alignment with regulatory requirements. **Continuous Improvement:** Lead projects aimed at improving product yield, efficiency, and overall quality. Use problem-solving methodologies, root cause analysis, and statistical techniques to identify and implement improvement opportunities. **General Engineering Tasks** + Fully competent engineer in all conventional aspects of quality engineering, functional areas, and assignments. + Plan and conduct work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria. + Devise new approaches to problems encountered, conducting root cause analysis and implementing corrective and preventive actions (CAPA) for quality issues. + Independently perform most assignments with general instructions on expected results. + Collaborate with cross-functional teams to create, review, and approve quality management system (QMS) procedures. + Plan, schedule, conduct, and coordinate detailed phases of technical work for part of a major project or in total projects of moderate scope. + Consult with supervisors concerning unusual problems and escalate complex issues when necessary. + May supervise or coordinate the technical work of engineers, technicians, or others involved in specific assignments. + Contribute to the development of new or improved processes, techniques, or procedures. **Qualifications** + Bachelor’s degree in Engineering, Life Sciences, or a related technical field. + 8+ years of experience in a quality engineering role or quality systems, preferably within the medical device industry. + Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and other applicable medical device regulations. + Experience with quality system integration and managing compliance during mergers or acquisitions is highly desirable. + Previous experience working in a clean room environment a plus. + Strong problem-solving skills, including experience with root cause analysis, corrective actions, and continuous improvement methodologies. + Ability to gather, analyze, and present quality metrics and data in a clear and actionable manner. + Familiarity with risk management processes, including identifying and mitigating product and process risks. + Excellent communication and interpersonal skills, with the ability to work effectively in cross-functional teams and support senior leaders. + Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word) and quality management software tools. + Must be available to travel ~25% of the time, as required, mainly domestic and some international Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All our teammate’s points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming. **JOIN OUR TALENT COMMUNITY** Joining our Talent Community is a great way to receive company news and updates, as well notifications on career opportunities and events that interest you! Please tell us more about yourself so we can align you with future opportunities that match your background, skills and interests. **Job Locations** _US-FL-Miami Lakes_ **ID** _2025-3316_ **Category** _Quality/Regulatory_ **Position Type** _Regular Full-Time_ CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact GlobalHR@Cordis.com