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
- Tactile Medical develops medical devices that support the treatment of edema and vascular diseases at home. It was founded in 1995, and is headquartered in Minneapolis, Minnesota, USA, with a workforce of 1001-5000 employees. Its website is https://tactilemedical.com.