Program Manager, Quality

Quality Program Manager

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 :

• 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 :

Preferred :

Working Conditions :

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.