Job Description

** THIS IS AN ENTRY LEVEL ROLE**

OVERVIEW: Perform all duties necessary to support Good Documentation Practices (GDP) and the Document Control department of the QA group in support of the manufacturing and sales of products manufactured by CODAN US CORPORATION.

JOB LOCATION: This position requires the employee to work at our office in Santa Ana (Orange County), CA location. There is not an option for remote work.

ABOUT THE COMPANY: CODAN US CORPORATION is part of the European-based CODAN Group of Companies, which for more than 50 years has been a market leader in the area of IV drug delivery systems to healthcare institutions around the world. From the beginning, CODAN product manufacturing standards have been based on a singular dedication to quality patient care. Today, we work closely with clinical practitioners to maintain our commitment to innovative clinical applications and new product development.

OUR COMMITMENT: The vital elements that enable CODAN to achieve its mission are our relationships with leaders in the medical community, our talented, trained, and committed employees, and our sense of responsibility to our customers and to the patients and caregivers whom they serve.

DUTIES AND RESPONSIBILITIES:

• Device Master Record (DMR) maintenance activities including but not limited to
• a. Engineering Change Order (ECO) revisions

b. Scanning and reviewing drawing

c. Scanning and reviewing labeling proofs

d. Reviewing updates

e. Logging updates

f. Final review and approvals

• 510(k) document search
• FDA GUDID submissions/corrections for existing and new products
• Device History Record (DHR) redline review and approvals for ECOs
• Maintenance of Calibration records
• Review and release of Document Change (DC) requests
• Administrative user for electronic Quality Management System (eQMS) solution Additional responsibilities include responding to any document change requests or questions related to document control across three (3) sights including international requests. A small amount of travel may be required to assist with document related inquiries and/or trainings.
• Other duties as assigned

REQUIREMENTS:

• High School Diploma or its equivalent.
• Excels in reading comprehension and technical writing.
• Excellent verbal and written communication skills.
• Ability to be a critical thinker.