TransMedics
Document Control Coordinator
TransMedics, Andover, Massachusetts, us, 05544
JOB DESCRIPTION
Title:
D ocument 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 proceduresMaintain continuity of digital files to ensure naming standards, appropriate file locations, format standardizationMaintain company documentation, as requiredInternal reporting for various company system metricsIssue controlled Laboratory Notebooks to cross functional departmentsAssign VV numbers to cross functional departmentsMaintain all Quality Records from inception to archival as hard files/electronic filesEnsure accuracy, quality, and integrity of all company documentsEnsure easy and efficient retrieval of documents internally and externallyAssist in updating device regulatory labels in label softwareAssist in training and maintain training with company training process within company PLM system and hard filesAssist with Quality AuditsUpdate and maintain Standards DatabaseScanning of Quality DocumentationEnsure ethics and compliance commitment at all timesMaintain confidentiality regarding sensitive documentationReview and update documents for maintenance and quality control with being audit ready as the goalPerform other TransMedics job-related tasks and duties, as assignedBACKGROUND and QUALIFICATIONS:
3-5 years’ experience working in a regulated industry; Quality Control experience strongly preferredProficient with Microsoft office softwareDocumentation Management Database experience preferredStrong organizational skills with the ability to work with a high degree of accuracyAttention to detailExceptional proof reading and quality control skillsExcellent interpersonal, verbal, and written communication skills. Ability to communicate effectively with all members of the companyFamiliarity with a Quality Management System or other regulated environment and the ability to adhere to all processes and proceduresEDUCATION:
High School diploma
Title:
D ocument 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 proceduresMaintain continuity of digital files to ensure naming standards, appropriate file locations, format standardizationMaintain company documentation, as requiredInternal reporting for various company system metricsIssue controlled Laboratory Notebooks to cross functional departmentsAssign VV numbers to cross functional departmentsMaintain all Quality Records from inception to archival as hard files/electronic filesEnsure accuracy, quality, and integrity of all company documentsEnsure easy and efficient retrieval of documents internally and externallyAssist in updating device regulatory labels in label softwareAssist in training and maintain training with company training process within company PLM system and hard filesAssist with Quality AuditsUpdate and maintain Standards DatabaseScanning of Quality DocumentationEnsure ethics and compliance commitment at all timesMaintain confidentiality regarding sensitive documentationReview and update documents for maintenance and quality control with being audit ready as the goalPerform other TransMedics job-related tasks and duties, as assignedBACKGROUND and QUALIFICATIONS:
3-5 years’ experience working in a regulated industry; Quality Control experience strongly preferredProficient with Microsoft office softwareDocumentation Management Database experience preferredStrong organizational skills with the ability to work with a high degree of accuracyAttention to detailExceptional proof reading and quality control skillsExcellent interpersonal, verbal, and written communication skills. Ability to communicate effectively with all members of the companyFamiliarity with a Quality Management System or other regulated environment and the ability to adhere to all processes and proceduresEDUCATION:
High School diploma