QMS Training Specialist

Omnicell • Cranberry Township, PA

9d • Hybrid

About The Position

The Quality Assurance team partners across Omnicell to consistently fulfill the needs of our customers by providing end-to-end quality support for our products and services through the execution of our QMS processes. The Quality Engineer III at Omnicell is responsible for ensuring our QMS Training is effectively created and delivered to all stakeholders. This role involves creating QMS training content, managing QMS training plans and training records, and establishing a training program that delivers the right training to the right people at the right time. The ideal candidate will be versatile, analytical, and detail-oriented, with strong communication and creative skills. The Quality Engineer III plays a pivotal role in driving continual improvement, while supporting the overall quality strategy, working closely with senior leadership and cross-functional teams to ensure compliance, optimize processes, and improve product quality. This position requires expert-level understanding of quality processes, strong leadership, and the ability to influence key decisions affecting the company's products and processes.

Requirements

• Minimum 4 years professional experience
• Bachelor's degree in Engineering or Science or Quality Management discipline
• Expert-level knowledge of QMS processes and regulatory standards (ISO 13485, FDA, etc.)
• Demonstrated ability to lead large-scale projects, including product and process improvement projects
• Strong leadership and decision-making skills, with the ability to influence cross-functional teams and senior leadership
• Expertise in training tools
• Exceptional communication skills and the ability to participate in audits and inspections

Nice To Haves

• Experience in process development
• Experience working in a regulated environment (i.e. ISO 9001, ISO 13485 or FDA regulated)
• Experience working with QMS Training (Learning Management Systems)
• Experience with large data migration from one LMS to another

Responsibilities

• Oversee the administration of the learning management system to support QMS training
• Creation of QMS training content and delivery of training content throughout Omnicell.
• Ensure training outcomes are effective and provide KPI's demonstrating effectiveness
• Manage and implement a new learning management system and successfully migrate data from current system.
• Champion continuous improvement initiatives, identifying opportunities to enhance and optimize internal training processes.
• Lead external audits and regulatory inspections, ensuring full compliance with ISO, FDA, and other relevant regulatory bodies.
• Develop and implement advanced quality metrics, presenting findings to senior leadership and driving actions to meet key performance indicators (KPIs).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees