Quality Documentation & Training Coordinator

Join our team and make a difference in the healthcare industry as a Quality Documentation & Training Coordinator, responsible for implementing and executing documentation, change control, and training processes to ensure compliance with company and regulatory requirements.

Requirements

• Initiates and executes an effective and efficient change control process in accordance to internal procedures
• Leads, facilitates, and mentors teams through all stages of the change control and training process
• Leads and participates in quality system improvement initiatives
• Interfaces between functions/departments such as Design, Quality and Operations in product, process, system, or supplier related changes
• Liaises with Change Requester and SMEs during all stages of the Change Control process, including Training process
• Supports and leads initiatives for continuous improvement
• Participates in project teams for change control
• Supports in training needs related to the change control process
• Manages periodic review process and procedures in applicable PLM Systems
• Supports in the preparation, participates, and addresses issues related to document and change management for internal and external (FDA, BSI, etc.) audits as needed
• Investigates and resolves non-conformances, audit observations, corrective and preventive actions (CAPAs) related to Change control and training process
• Assists in the creation and development of metrics to evaluate the effectiveness and efficiency of Change Control Processes
• May support onboarding training for new employees; collaborate with managers to align onboarding content with role-specific needs.
• Monitor training completion, generate compliance reports, and collaborate with stakeholders to ensure compliance.

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan