Quality Training & Document Specialist

Company Overview: 

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. specializes in developing innovative medical devices aimed at addressing challenging cardiac and vascular conditions. Our Austin facility houses a diverse team dedicated to producing the On-X Mechanical Heart Valves. With over 1,400 employees globally and manufacturing sites in Atlanta, Austin, and Hechingen, Germany, Artivion serves healthcare professionals in over 100 countries. For more details, visit our website at www.artivion.com.

Position Objective:

Responsible for the independent administration, maintenance, and continuous improvement of the Quality training program and controlled documentation processes to ensure compliance with internal procedures and external regulatory requirements. Partners with cross-functional stakeholders to implement training structures, maintain curricula and learning records, monitor compliance status, support investigations and CAPA actions, and ensure document control workflows in the eQMS are complete, accurate, and effective. Serves as a knowledgeable resource to the business on training and document control processes, system use, and compliance expectations.

Responsibilities:

Essential functions include, but are not limited to:

• Accurate and timely administration of training curricula, assignments, completions, and records within the eQMS. Independently administer assigned components of the Quality training program and document control processes within the eQMS, ensuring compliance with internal procedures and applicable regulatory requirements.
• Exercises independent judgment within established quality systems and procedures to resolve routine-to-moderately complex training and document control issues.
• Review, validate, and implement training change requests, curriculum updates, and user access or workflow updates in accordance with established quality standards.
• Partner with department managers, training coordinators, and subject matter experts to define training assignments, role-based training matrices, and learning paths that support job competency and compliance.
• Timely identification, communication, and follow-up of training compliance risks and overdue items. Maintain and monitor training records, curricula, dashboards, and reports; analyze completion trends, identify compliance risks, and escalate gaps or overdue training to management.
• Deliver QMS onboarding and refresher training and provide process guidance to users, coordinators, and managers on training requirements, documentation control practices, and effective use of training systems.
• Does not have direct people management responsibility, but will serve as department designee on behalf of the department manager when necessary.
• Identifies process gaps, recommends corrective actions, and supports implementation of sustainable improvements. Investigate training record discrepancies, workflow issues, and user-reported system problems; determine appropriate corrective action or escalation path and coordinate resolution with internal stakeholders or system support.
• Effective support of audits, inspections, investigations, and CAPA actions related to training and documentation. Support nonconformance, CAPA, and audit activities related to training and document control by gathering records, analyzing issues, implementing assigned actions, and helping drive sustainable process improvements.
• Compliant execution of document control workflows, including record quality, routing, approval, and archival readiness. Act as system administrator for document control, review controlled documents submitted into the eQMS for completeness, formatting, legibility, metadata accuracy, and routing readiness prior to release or approval.
• Monitor document routing and approval workflows, follow up with stakeholders to resolve bottlenecks, and help ensure documents are processed within defined timelines.
• Generate and maintain KPI metrics for training and document control processes; summarize trends, recurring issues, and areas requiring management attention.
• Measurable improvement in training and document control process efficiency, data quality, and audit readiness. Recommend and support implementation of process improvements to strengthen compliance, efficiency, user experience, and audit readiness.
• Serve as a day-to-day resource to stakeholders regarding training administration, document control practices, and quality system process expectations.
• Maintain physical and electronic training records in accordance with retention and archival requirements.
• Provide backup support for scanning, archival, and related records administration activities as needed.
• Support internal and external inspections and audits by preparing requested records, explaining process execution, and demonstrating training/document control compliance.
• Prioritizes and manages multiple requests, compliance deadlines, and stakeholder needs with limited day-to-day direction.
• Perform other related duties as assigned.
  Management retains the discretion to add or change the duties of the job at any time to support current business needs.

Qualifications:

• Bachelor’s degree, preferably in Life Sciences, or equivalent work experience.
• Minimum of 4 years’ experience in the medical device or equivalent regulated industry.
• Working knowledge of ISO 13485 and other regulations/standards applicable to training.
• Must be proficient in MS Office.
• Knowledge of eQMS system and training methodologies preferred.
• Strong interpersonal and communication skills.
• Strong organizational skills and highly detail-oriented.
• Strong sense of urgency and ability to complete accurate work within deadlines.