Quality System Process Coordinator

Tactilemedical; New Brighton (MN); On-site; USD 33,062 - 42,705; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Paid time off

Job summary

Tactile Medical is seeking a Quality System Process Coordinator to manage the electronic quality system (GAS) and related modules. You will oversee configuration, training management, and ensure compliance with procedures while analyzing metrics to drive improvements.

Ideal candidates bring a Bachelor's degree or equivalent and 3+ years in a regulated medical device quality environment. Preference for prior GAS experience and strong MS Office skills to support cross-functional teams.

Qualifications

• Bachelor's degree or equivalent work experience.
• 3+ years quality system experience in regulated medical device industry.
• Experience with Grand Avenue Software preferred.

Responsibilities

• Administer GAS system with focus on configuration and training management.
• Maintain integrity of underlying GAS system configuration.
• Provide analysis and recommendations for GAS configuration improvements.
• Monitor metrics for quality system goals and report findings.
• Develop and maintain GAS training assessment requirements.
• Interface with departments on GAS changes and updates.
• Ensure compliance of GAS changes with procedures.
• Review configuration requests for feasibility and impact.
• Manage GAS-related email inbox and provide timely feedback.
• Coordinate cross-functionally on system changes.

Skills

Microsoft Office proficiency

Training development

Project management

Quality system concepts

Cross-functional communication

Education

Bachelor's degree or equivalent

3+ years quality system experience

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
• 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

Compensation and Benefits

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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