Tactile Medical

Markets at-home pneumatic compression therapies

Quality System Process Coordinator

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeNew Brighton, MN, USA$23.89 - $31.35In-person

About the Job

Requirements

A bachelor's degree or equivalent work experience is required.
At least 3 years of quality system experience in the regulated medical device industry is required.
Strong proficiency in Microsoft Office Suite, including Word, Excel, Teams, and PowerPoint.
Ability to develop training or other resources relating to quality system updates that are clear, concise, and communicable to all organizational levels.
Ability to manage multiple tasks simultaneously.
Ability to use data from metrics and key data points.
Understanding of the business and products, including department processes and overall objectives.
Ability to work independently and as part of 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.

Responsibilities

Administer the Grand Avenue Software (GAS) system, with particular focus on configuration and training management.
Maintain the integrity of the underlying system configuration.
Analyze and recommend improvements to configurations and the 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 regarding changes and updates to GAS.
Review current configuration structures and ensure compliance with new or updated procedures.
Ensure changes made to GAS are reflected in 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 cross-functional communication and interaction regarding system changes.
Regularly review quality system metrics and identify areas for improvement.
Assist in compiling quarterly reports on GAS data and semiannual reports for management review.
Serve as the subject matter expert for GAS.
Interface directly with GAS to make functional requests or troubleshoot issues.
Ensure continued compliance with regulatory requirements for all changes made within GAS.
Assist with development and implementation of the GAS training effectiveness module.
Assist in developing additional training resources, such as job aids and short tutorials, for 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 quality management system (QMS) and/or GAS are adequate and routinely updated.
Routinely monitor GAS training requirements to ensure training is completed on time.
Perform other duties as assigned.

Desired Qualifications

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

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.

Accountabilities & 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
GAS Configurations
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
Training Assessments
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.

Education & Experience
Required:

Bachelor’s degree or equivalent work experience
3+ years’ quality system experience in regulated medical device industry

Preferred:

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

Knowledge & Skills

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

Our total compensation package includes medical, dental and vision benefits, retirement benefits, employee stock purchase plan, paid time off, parental leave, family medical leave, volunteer time off and additional leave programs, life insurance, disability coverage, and other life and work wellness benefits and discounts. Benefits may be subject to generally applicable eligibility, waiting period, contributions, and other requirements and conditions.

Below is the starting salary or hourly range for this position, although offers may differ based on the candidate's location, job-specific knowledge, skills and experience.

US Pay Range

$23.89—$31.35 USD

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US Pay Range 23.89 - 31.35 USD

About the Company

Tactile Medical

Markets at-home pneumatic compression therapies

Tactile Medical develops and markets at-home pneumatic compression therapies for chronic swelling conditions such as lymphedema, lipedema, and chronic venous insufficiency, with devices like the Flexitouch Plus and Nimbl for home use. The devices deliver controlled air pressure to limbs to stimulate the lymphatic system and improve fluid flow, reducing swelling, and are supported by clinical education and customer service to ensure proper use. It differentiates itself by offering a full continuum of care—home devices plus ongoing education and support—so patients can manage these conditions outside the clinic. Its goal is to improve the quality of life for patients with underserved chronic conditions by enabling ongoing, at-home management and support; the company trades on Nasdaq under the ticker TCMD.

Company size: 1,001-5,000
Company stage: IPO
Headquarters: Minneapolis, MN
Founded: 1995

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