Program Manager, Selution

$122,650 - $154,000/Yr

Cordis - Irvine, CA

Full-time - Mid Level

Irvine, CA

Miscellaneous Manufacturing

About the position

The Quality Program Manager at Cordis is responsible for managing quality programs and overseeing the Quality Management System (QMS) for the Selution Drug Eluting Balloon (DEB). This role focuses on managing change, ensuring compliance with regulatory requirements, and driving process improvements to enhance product quality and operational efficiency. The position requires collaboration with cross-functional teams and aims to foster a culture of quality excellence within the organization.

Responsibilities

• 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.
• Act as the integration quality program manager for Selution DEB, incorporating current integration initiatives into the QMS.
• Serve as the QMS lead for Selution DEB, addressing current gaps/improvements and leading QMS improvement plans.
• Work closely with the Cordis audit team as an Audit Subject Matter Expert (SME) for audit-related activities.
• Facilitate training initiatives for the Selution team, leveraging internal and external resources for training needs.
• Champion continuous improvement initiatives within the QMS, focusing on process optimization and data-driven decision-making.
• Mentor and provide QMS and program management guidance to junior engineers.

Requirements

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Science, or a related field.
• At least 5 years of experience in a medical device QMS role.
• Demonstrated 15 years of experience in the medical device industry in lieu of an engineering degree.
• Strong engineering or science and quality background.
• Proven track record in global regulatory body interactions.
• Strong project management and organizational skills.

Nice-to-haves

• FDA PMA experience with combination devices.
• Formal training in program management and change management.
• Previous experience working in a clean room environment.

Benefits

• Competitive salary range of $122,650 - $154,000 per year.
• Equal opportunity employer with a commitment to diversity and inclusion.