Quality System Process Coordinator

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.

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 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 aides, 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 is 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