Document Control Coordinator

Tactile Medical specializes in developing at-home therapy devices for various health conditions. The Document Control Coordinator is responsible for managing documentation processes, ensuring compliance with quality systems, and providing support to site personnel.

Responsibilities

• Maintain and support administrative role in Grand Ave Software DCR module
• Support the documentation process by preparing, reviewing, routing and releasing documents used in assembly, and operations, as well as quality system documents and corporate policies
• Expedite document changes to completion and distribution, while ensuring compliance with Quality System procedures and templates where applicable
• Support and manage all offsite storage and preparation of boxes to the storage facility
• Support administration tasks in Grand Avenue and coordinating tasks as appropriate
• Support system changes for adding, removing, and updating employees and their access and/or responsibilities
• Facilitate, communicate and manage changes to released documents, with appropriate priority, through internal and external customers
• Analyze change activities to ensure adherence to quality procedures
• Monitor DCR metrics on a routine basis to ensure goals are met
• Support audits of documentation workflow and provide feedback on potential improvements
• Provide support and training on methods, procedures and requirements for the documentation team and site personnel
• Other duties as assigned

Skills

• High School Diploma or GED
• 1+ years of experience in documentation/document control
• 1+ years of experience in a medical device or other regulated industry
• Previous experience working with Grand Avenue, or similar electronic quality system
• Demonstrated ability to organize, prioritize, multitask and meet deadlines
• Strong attention to detail
• Knowledge and understanding of release, change request and change implementation processes
• General ability to read and understand a variety of documentation types, such as engineering reports, design specifications, work instructions, etc
• Proficient in MS Office Products, particularly Word and Excel
• Knowledge of electronic signature platforms such as Adobe Acrobat, DocuSign, or similar
• Excellent verbal and written communication skills with the ability to communicate effectively with individuals of all levels
• Knowledge of medical device regulations (21CFR820, ISO 13485) or another regulated industry

Benefits

• Medical
• Dental and vision benefits
• Retirement benefits
• Employee stock purchase plan
• Paid time off
• Parental leave
• Family medical leave
• Volunteer time off
• Additional leave programs
• Life insurance
• Disability coverage
• Other life and work wellness benefits and discounts

Company Overview