Quality Training 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 1,600 employees globally and manufacturing sites in Atlanta, Austin, and Hechingen, Germany, Artivion serves healthcare professionals in over 100 countries. For more details on the On-X Mechanical Heart Valve, click here.

Position Objective:

Ensure that the Quality training program is effective and compliant with both internal procedures and external regulatory requirements. The training 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. Training needs are identified and delivered to improve workplace performance and align with the company's core values. 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:

• Coordinate the QMS site training programs to ensure training effectiveness and compliance to internal procedures and external regulatory requirements.
• Maintain and deliver QMS-related training to facilitate QMS implementation across the organization.
• Maintain and deliver QMS-related onboarding training to New Hires and refresher training as needed. Assist with facility tours as needed.
• 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.
• Collaborate across functional areas to develop and align the site training requirements.
• Support managers and learners with day-to-day training activities such as curriculum identification, assignments, and training process understanding.
• Provide education of training software to users and provide administrative support of password resets, tracking reported technical issues, and updates requested from users.
• Maintain user accounts for employees in training software. Add, terminate, inactivate, reactivate, transfer users and update training requirements as needed.
• Maintain confidentiality regarding sensitive employee information and records.
• Review training requirements and curriculum within required intervals to ensure training content remains current and updated.
• Monitor and track training. Provide key training metrics to evaluate training effectiveness.
• Create training reports/dashboards to assess and communicate training status to ensure on-time training. Report to management late or upcoming training.
• Assist with investigations and corrective action planning related to training (NC/CAPA) and implementation of training process improvements.
• Support and participate in audits/inspections as required.
• Act as liaison between users and training software Technical Support, in order to troubleshoot and resolve technical issues as they arise.
• Assist in upgrade testing and system validation for training software as needed
• Assist other departments' unique training systems with maintenance and implementation of specific training outside of QMS. Provide technical support to users of these systems.
• Assist with Document Control functions such as routing documents for approval.
• Other duties as assigned.

Other responsibilities as assigned.

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.

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.