Document Control Coordinator II

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

Job Summary and Responsibilities

Manages documents and change control processes ensuring proper document number assignment, timely review / approval, release, and distribution of controlled documents.

Maintains training matrix, assigns training, and ensures timely completion of training in accordance with the change order implementation plan.

Performs data entries for part updates according to document change orders.

Performs general filing and record keeping for controlled documents and quality records.

Assists with annual document and data review.

Reviews and maintains documentation log / index on a regular basis to ensure data integrity.

Assists with HR activities for onboarding process as needed.

Provides support for audit activities as needed.

Supports ongoing effort of process improvement activities such as CAPA and / or procedure updates.

Performs other quality related duties as assigned.

Qualifications

Required Qualifications

College degree preferred

2+ years managing documentation and change controls in a regulated environment

2+ years of related experience in the Medical Device industry

Competencies & Skills

Precise, Rigorous, Detail-Oriented

Good communication and interpersonal skills.

Supportive, keen to promote quality through example and continuous support.

Fluent in English

Pay / Compensation

The expected pre-tax pay rate for this position is $20.63 - 30.94 per hour. 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

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities

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.

JOIN OUR TALENT COMMUNITY

Joining our Talent Community is a great way to receive company news and updates, as well notifications on career opportunities and events that interest you! Please tell us more about yourself so we can align you with future opportunities that match your background, skills and interests.

Job Locations US-CA-Irvine

ID 2025-12107

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 GlobalHR@Cordis.com