Quality System Process Coordinator

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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