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Document Control Coordinator

2 months ago


Andover, United States TransMedics Full time

Document Control Coordinator Location: Andover, MA Time Type: Full time Posted On: Posted 13 Days Ago Job Requisition ID: R-100096 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, and 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 proofreading 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. TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees. #J-18808-Ljbffr