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 / CompensationThe 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.

Salary : $21 - $31