Quality Program Manager, Selution Cordis - 4.4 Irvine, CA Job Details Full-time $122,650 - $154,000 a year 11 hours ago Qualifications Program management 5 years Writing skills Engineering Mechanical Engineering Biomedical Engineering English Quality management Project management Bachelor's degree Organizational skills Cleanroom Senior level FDA regulations Full Job Description Overview: Cordis is a pioneering medical technology company specializing in groundbreaking solutions for cardiovascular and peripheral vascular diseases. Our flagship product, SELUTION, combines pharmaceuticals with a traditional balloon catheter, revolutionizing treatments for coronary and peripheral artery diseases. With four Investigational Device Exemptions (IDEs) approved and actively enrolling patients (Coronary ISR, Coronary De Novo, Peripheral SFA, and Peripheral BTK), Cordis is leading the way in delivering transformative medical solutions. Selution Drug Eluting Balloon offers a unique opportunity for next generation peripheral and coronary therapy. The Selution DEB is evolving rapidly with commercial scaling and product development for new markets, as such we are hiring the required infrastructure to bring this class leading technology to a global scale. If you love a challenge and are ready to have a direct, positive impact on the lives of millions, then this is 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. The Quality Program Manager will be responsible for managing quality programs, initiatives and overseeing the QMS for Selution DEB. The primary focus will be on managing change, overseeing the integration with Cordis, scaling production capacity, and developing and implementing an ISO-compliant Quality Management System (QMS). Additionally, the role will ensure compliance with regulatory requirements, standards, and customer needs. The position will collaborate with cross-functional Selution teams, be the main point of contact for the Cordis supporting teams, drive process improvements, and champion a culture of quality excellence. Responsibilities: Key Accountabilities Lead change management initiatives, coordinating the Change Control Board (CCB) and managing bi-weekly reviews for post-approval programs. Collaborate cross-functionally to develop and implement quality plans for each initiative or program. Integration quality program manager for Selution DEB: Incorporate current integration initiatives into the QMS, team member on current and future integration efforts responsible for representing and delivering quality elements of the QMS QMS lead for Selution DEB: Site representative for the QMS, addressing current gaps/improvements and leading QMS improvement plans. Audit SME: working closely with the Cordis audit team, represent the Selution team locally on audit related activities Facilitate training initiatives for the Selution team: working with the internal training team, leveraging Cordis resources and coordinating external resources for the provision of training needs. Other potential areas requiring program and QMS management include MRB, CAPA board. Future initiative will include: Risk Management: transfer of the risk management discipline into quality. Complaints: transfer of technical complaint evaluation into the quality function. MDSAP: establishing and coordinating the MDSAP effort. Champion continuous improvement initiatives within the QMS, focusing on process optimization, data-driven decision-making, and fostering a culture of quality excellence to enhance product quality and operational efficiency. Mentor and provide QMS and program management guidance to junior engineers, fostering their professional growth and development within the organization. Strategic Impact Enable tactical execution of the business priorities. Escalate any resource or strategic conflicts to cross functional and senior leadership. Work closely with the other functional program managers to align on functional ownership in the execution of the overall business priority listing Key Interactions Reports to a senior leadership position. Potential to interact with all functions including suppliers and customers depending on the topic/project being led or supported. Qualifications: Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Science or a related field. In lieu of an engineering degree, demonstrated 15 years experience in industry medical device pre/post market aligned with this job description will qualify. At least 5 years experience in a medical device QMS role. FDA PMA experience with combination devices [preferred] Formal training in program management and change management. [preferred] Previous experience working in a clean room environment [preferred] Competencies & Skills Strong engineering or science and quality background Team Leader, ability to inspire and support a team. Proven track record in global regulatory body interactions Strong project management and organizational skills, with demonstrated experience in managing cross-functional teams and meeting project deadlines. Excellent writing and documentation skills Ability to make independent decisions Fluent in English Pay / Compensation The expected pre-tax pay rate for this position is $122,650 - $154,000 Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location. US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa. 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.