Artivion, Inc. · 12 hours ago
Quality Training & Document Specialist
Austin, TX
Full-time
Onsite
Mid Level
4+ years expArtivion, Inc. is a company specializing in innovative medical devices for cardiac and vascular conditions. The Quality Training & Document Specialist will ensure the effectiveness and compliance of the quality training program and support training and document management processes across the organization.
Biotechnology
Responsibilities
Complete eQMS updates and training requests via the ticketing application
Provide education of training software to users and provide administrative support of password resets, tracking reported technical issues, and updates requested from users
Maintain physical training files ensuring they are scanned in the eQMS and for archiving upon employee separation
Perform monthly metrics for KPIs
Interface with department managers, training coordinators, and Subject Matter Experts at all levels to consult on development and maintenance of training program and setup in software to demonstrate competence in job function and objectives
Assist with generating organizational departmental training plans
Maintain and deliver QMS-related onboarding training to New Hires and refresher training as needed. Assist with facility tours as needed
Create training reports/dashboards to assess and communicate training status to ensure ontime training. Report to management late or upcoming training
Assist with investigations and corrective action planning related to training (NC/CAP A) and implementation of training process improvements
Support and participate in audits/inspections as required
Act as liaison between users and training software Technical Support, to troubleshoot and resolve technical issues as they arise
Ensure that all documents entered into the eQMS Documentation System are checked for legibility and completeness. Ensure that drawings are complete, clear, readable and properly recorded. Ensure changes made to documents are accurately reflected in documentation change records
Ensure Change Control Records are being appropriately managed and maintained
Ensure documents are routed and approved in a timely manner
Provide back-up coverage for scanning original records into electronic media and for archiving originals
Supports audits, types and files for other departments, retrieves information for engineers and managers
Other duties as assigned
Qualification
Required
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
Self-starter and able to work independently
Preferred
Knowledge of eQMS system and training methodologies preferred
Benefits
Comprehensive Medical, Dental, and Vision
Life Insurance
Supplemental Benefits
401(k) with both Traditional and Roth options available
Employee Stock Purchase Plan (ESPP)
10 Paid Company Holidays
Competitive PTO plan
Tuition Reimbursement
Company
Artivion, Inc.
Artivion is a leader in the manufacturing, processing, and distribution of medical devices and implantable tissues used in cardiac and vascular surgical procedures focused on aortic repair.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Pat Mackin
President & CEO
Ashley Lee
EVP, COO & CFO
Company data provided by crunchbase