Document Control Coordinator

at  Transmedics Inc

JOB DESCRIPTION

Title: Document Control Coordinator
Reports to: Document Control Manager

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

• 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