Quality Training & Document Specialist

Artivion, Inc.•Austin, TX

3d•Onsite

About The Position

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.

Requirements

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.
Strong interpersonal and communication skills.
Strong organizational skills and highly detail-oriented.
Strong sense of urgency and ability to complete accurate work within deadlines.

Nice To Haves

Knowledge of eQMS system and training methodologies preferred.

Responsibilities

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.
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.

Benefits

Generous Time Off: Enjoy 5 weeks of Paid Time Off (PTO), accrued throughout the year, plus 10 paid company holidays
Health & Wellness: Comprehensive medical, dental, and vision coverage, along with life insurance and supplemental benefits
Retirement Planning: 401(k) with up to a 4% company match (Traditional and Roth options available)
Employee Stock Purchase Plan: Purchase Artivion stock at a discounted rate and share in our company’s success
Work-Life Balance: Benefit from a consistent and predictable work schedule
Education Support: Tuition reimbursement to support your continued growth and development
Employee Assistance Program (EAP): Access confidential resources for personal, financial, and emotional well-being
Legal Benefits (LegalShield): Includes legal consultation, document review, will preparation, and 24/7 emergency access
Financial Wellness: Access tools and resources through the Truist Momentum program
Employee Discounts: Enjoy savings through Working Advantage, offering discounts on travel, entertainment, and more
Efficient Hiring Process: We value your time and offer a streamlined interview process with timely feedback and decisions