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:

Ensure that the Quality training program is effective and compliant with both internal procedures and external regulatory requirements.  The training and document specialist will support corporate and site training by collaborating with cross functional teams to develop and maintain training programs, assist with curriculum and course content, and monitor training status for training completion. Assist with management and control of all Artivion documents and administrative functions of the eQMS module. To ensure that all areas outlined under “Principal Responsibilities” are accomplished in an efficient, professional manner to support Artivion, Inc.

Responsibilities:

Essential functions include, but are not limited to:

• 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.

Note:  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.
• Self-starter and able to work independently.

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

Equal Employment Opportunity Employer (EEO):
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected status under applicable law.