Quality System Process Coordinator New Brighton, Minnesota

Tactile Medical; New Brighton (MN); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Medical, dental and vision benefits

Retirement benefits (401(k))

Employee stock purchase plan

Paid time off and parental leave

Job summary

Tactile Medical is seeking a Quality System Process Coordinator to manage and improve the electronic quality system (GAS) and related modules. You will administer configuration, training programs, and cross-functional changes to ensure compliance with regulatory requirements.

The role focuses on monitoring metrics, generating reports, and acting as the GAS SME. Strong problem solving, attention to detail, and ability to work independently within a team are essential.

Qualifications

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

Responsibilities

• Administer GAS system with focus on configuration and training management.
• Maintain integrity of underlying system configuration.
• Provide analysis and recommendations for improvement to configurations and GAS structure.
• Monitor metrics associated with quality system goals.
• Develop, implement and maintain Training Assessment requirements related to the quality system.

Skills

Microsoft Office

Training materials

Multitasking

Data-driven decisions

Communication

Education

Bachelor’s degree or equivalent

Tools

Grand Avenue Software

Job description

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
• 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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Tactile Medical’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.