Quality System Process Coordinator

Tactile Medical•New Brighton, MN

6d•$24 - $31

About The Position

At Tactile Medical, we specialize in developing at-home therapy devices to treat lymphedema, chronic venous insufficiency and respiratory illnesses. The Quality System Process Coordinator is responsible for overall management and improvement of the electronic quality system and ancillary modules used within Grand Avenue Software (GAS) by performing the roles as described herein.

Requirements

Bachelor’s degree or equivalent work experience
3+ years’ quality system experience in regulated medical device industry
Strong proficiency in Microsoft Office Suite, including Word, Excel, Teams and PowerPoint
Ability to development training and/or other resources relating to quality system updates that are clear, concise, and can be communicated to all levels of an organization
Ability to successfully manage multiple tasks at one time
Ability to utilize data from metrics and key data points
Understanding of the business and products (Department processes and overall objectives)
Ability to work independently and amongst a team
Ability to communicate effectively with employees at all levels of the business
Strong problem solving and critical thinking skills
High attention to detail and accuracy
Ability to organize and plan activities that drive and meet deadlines

Nice To Haves

Previous experience with Grand Avenue Software
Previous quality system management/improvement experience
Experience analyzing quality system processes

Responsibilities

Administer the GAS system with particular focus on configuration and training management
Maintain integrity of underlying system configuration
Provide analysis and recommendation for improvement to configurations and overall GAS structure
Monitor metrics associated with quality system goals
Develop, implement and maintain Training Assessment requirements related to the quality system
Interface with various departments on changes and updates to GAS
Review current configuration structures and ensure compliance with new/updated procedures
Ensure changes made to GAS are carried through to the associated procedures
Review system configuration requests to determine feasibility and downstream impacts
Manage the email inbox related to GAS requests and provide timely feedback
Initiate communication and interaction cross-functionally regarding system changes
Perform regular reviews of quality system metrics and identify areas for improvement
Assist in compiling quarterly reports on GAS data, and semi-annually for Management Review
Function as the subject matter expert for GAS
Interface directly with GAS for necessary functional requests or troubleshooting of any issues
Ensure continued compliance with regulatory requirements for all changes being made within GAS
Assist with development and implementation of the GAS training effectiveness module
Assist in development of additional training resources (e.g., job aids, short tutorials, etc.) that can be referenced by GAS users
Provide GAS training to new users as needed
Maintain detailed training records within GAS
Participate in cross-functional activities to ensure training resources related to the QMS and/or GAS are adequate and routinely updated
Routinely monitor GAS training requirements to ensure training is completed on time
Other duties as assigned.