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Cordis · 2 months ago

Program Manager, Quality

Irvine, California

Full-time

Onsite

Senior Level, Lead/Staff

8+ years exp

Cordis is a company specializing in advanced drug device combination products for the treatment of coronary and peripheral artery disease. They are seeking a Quality Program Manager to oversee quality programs and the Quality Management System (QMS) for the Selution Drug-Eluting Balloon platform, ensuring compliance with global regulatory standards and promoting a culture of quality excellence.

Health CareHealth DiagnosticsMedical

No H1B

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

Qualification

Project ManagementLeadershipFDA PMA ExperienceChange ManagementCleanroom ExperienceOrganizational SkillsCross-Functional Collaboration

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