Overview
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.
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 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 proceduresEnsure changes made to GAS are carried through to the associated proceduresReview system configuration requests to determine feasibility and downstream impactsManage the email inbox related to GAS requests and provide timely feedbackInitiate communication and interaction cross-functionally regarding system changesPerform regular reviews of quality system metrics and identify areas for improvementAssist in compiling quarterly reports on GAS data, and semi-annually for Management ReviewFunction as the subject matter expert for GASInterface directly with GAS for necessary functional requests or troubleshooting of any issuesEnsure continued compliance with regulatory requirements for all changes being made within GASTraining Assessments
Assist with development and implementation of the GAS training effectiveness moduleAssist in development of additional training resources (e.g., job aides, short tutorials, etc.) that can be referenced by GAS usersProvide GAS training to new users as neededMaintain detailed training records within GASParticipate in cross-functional activities to ensure training resources related to the QMS and / or GAS are adequate and routinely updatedRoutinely monitor GAS training requirements to ensure training is completed on timeOther duties as assigned.
Qualifications
Education & Experience
Required :
Bachelor's degree or equivalent work experience3+ years' quality system experience in regulated medical device industryPreferred :
Previous experience with Grand Avenue SoftwarePrevious quality system management / improvement experienceExperience analyzing quality system processesKnowledge & Skills
Strong proficiency in Microsoft Office Suite, including Word, Excel, Teams and PowerPointAbility 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 organizationAbility to successfully manage multiple tasks at one timeAbility to utilize data from metrics and key data pointsUnderstanding of the business and products (Department processes and overall objectives)Ability to work independently and amongst a teamAbility to communicate effectively with employees at all levels of the businessStrong problem solving and critical thinking skillsHigh attention to detail and accuracyAbility to organize and plan activities that drive and meet deadlinesBelow is the starting salary range for this position, although offers may differ based on the candidate's location, job-specific knowledge, skills and experience.
$25.77 - $36.04 / HR
Additional benefits :
non-exempt - 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.