Document Control Coordinator

JOB DESCRIPTION

Title: Document Control Coordinator

Reports to: Document Control Manager

ESSENTIAL RESPONSIBILITIES AND DUTIES INCLUDE:

• Assist Document Control Manager with Document Control PLM system in support of other departments, in accordance with policies and procedures

• Maintain continuity of digital files to ensure naming standards, appropriate file locations, format standardization

• Maintain company documentation, as required

• Internal reporting for various company system metrics

• Issue controlled Laboratory Notebooks to cross functional departments

• Assign VV numbers to cross functional departments

• Maintain all Quality Records from inception to archival as hard files/electronic files

• Ensure accuracy, quality, and integrity of all company documents

• Ensure easy and efficient retrieval of documents internally and externally

• Assist in updating device regulatory labels in label software

• Assist in training and maintain training with company training process within company PLM system and hard files

• Assist with Quality Audits

• Update and maintain Standards Database

• Scanning of Quality Documentation

• Ensure ethics and compliance commitment at all times

• Maintain confidentiality regarding sensitive documentation

• Review and update documents for maintenance and quality control with being audit ready as the goal

• Perform other TransMedics job-related tasks and duties, as assigned

BACKGROUND and QUALIFICATIONS:

• 3-5 years' experience working in a regulated industry; Quality Control experience strongly preferred

• Proficient with Microsoft office software

• Documentation Management Database experience preferred

• Strong organizational skills with the ability to work with a high degree of accuracy

• Attention to detail

• Exceptional proof reading and quality control skills

• Excellent interpersonal, verbal, and written communication skills. Ability to communicate effectively with all members of the company

• Familiarity with a Quality Management System or other regulated environment and the ability to adhere to all processes and procedures

EDUCATION:

• High School diploma