Document Control Coordinator

2 weeks ago

Andover, United States TransMedics Full time
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

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