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Overview

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

Responsibilities

The Quality Program Manager oversees and manages quality programs, initiatives, and the Quality Management System (QMS) for the Selution Drug-Eluting Balloon (DEB) platform. This role focuses on driving change management, integration with Cordis systems, production scale-up, and implementation of ISO-compliant QMS processes. The position collaborates cross-functionally to ensure compliance with global regulatory standards and to champion a culture of quality excellence throughout the organization.

Key Responsibilities

+ Lead and coordinate change management initiatives, including Change Control Board (CCB) reviews for post-approval programs.

+ Manage integration activities, representing the Selution DEB team in cross-functional quality initiatives and QMS alignment with Cordis.

+ Serve as the site lead for QMS implementation, addressing gaps, driving improvements, and managing quality system enhancements.

+ Act as audit subject matter expert, supporting local and global audit readiness and coordination with the Cordis audit team.

+ Collaborate with Training, HR, and Cordis teams to implement quality and compliance training for the Selution organization.

+ Oversee key quality processes including MRB, CAPA, and Risk Management integration.

+ Support future quality initiatives including MDSAP compliance and complaint handling process integration.

+ Promote continuous improvement using data-driven metrics to optimize processes and increase efficiency.

+ Provide mentoring and guidance to junior engineers and quality teammates on program and QMS best practices.

+ Escalate strategic or resource conflicts to senior leadership for resolution and alignment

Qualifications

Required:

+ Minimum of 8+ years of relevant experience

+ Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or related field or equivalent education and experience; or 6+ years and a Master’s degree; or a PhD with 3+ years’ experience; or equivalent experience.

+ Strong project management and organizational skills.

+ Proven leadership in cross-functional environments.

Preferred:

+ FDA PMA experience with combination devices.

+ Formal training in program or change management.

+ Experience working in a cleanroom environment.

Working Conditions

+ Primarily office-based work with occasional cleanroom interaction.

+ Light lifting (up to 20 lbs.)

+ Ability to travel up to 10% domestically or internationally.

+ May require occasional telecommuting flexibility

Pay / Compensation

The expected pre-tax pay rate for this position is $ $122,650 - $154,000 per year. 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.

Preferred Qualifications

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 teammates’ 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.

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**Job Locations** _US-CA-Irvine_

**ID** _2025-12251_

**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 [email protected]