This role manages Technical Training team members to ensure the successful alignment and execution of Technical Training strategies, initiatives, and processes. 

What You Will Do 

• Lead and develop a team responsible for the coordination, deployment, and management of role-based technical training programs. 

• Ensure Quality Key Performance Indicators (KPIs), training processes, records, and curricula comply with regulatory requirements, quality standards, and internal procedures. 

• Complete training workflow tasks within the Change Control process to ensure accurate training is planned and assigned in the LMS when new or revised documents are released. 

• Develop, maintain, evaluate, and continuously improve training systems, standards, and processes to ensure effective training delivery and overall program effectiveness. 

• Partner with functional groups (e.g., Manufacturing, Quality, Regulatory, Compliance, HR) to incorporate functional training requirements into role-based curricula and ensure accurate training assignments. 

• Present training performance metrics to leadership during periodic meetings and forums (e.g., Quality Systems Management Review). 

• Review, approve, and execute training-related QMS change control tasks. 

• Monitor and respond to changes in LMS data that may impact the reliability and/or automation of training assignments. 

• Update training procedures, plans, and supporting documentation as required. 

• Represent Technical Training processes during regulatory audits and inspections, providing training records and qualification evidence as needed. 

• Provide support for NC/CAPAs related to training outcomes or training processes. 

• Perform additional duties and projects as assigned. 

What You Will Need 

• Bachelor’s degree in Business, Education, Human Resources, or related discipline. 

• Minimum of 5 years of experience in medical device, supporting quality, compliance, manufacturing, operations, or technical training programs. 

• Experience managing one or more remote team members. 

• Ability to work with repetitive, detail-oriented tasks that require a high degree of accuracy 

• Strong understanding of QMS requirements 

• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.)  

• Fluent in written and oral English – C1 Level (writing documents, meeting minutes, conference calls, etc.) 

• Knowledge of Good Manufacturing Practices (GMPs) and ISO 13485 regulations. 

• Well versed with MS Office tools such as Word and PowerPoint; highly proficient with Excel spreadsheets. 
• A valid U.S. visa is required

Preferred

• Experience supporting training programs within manufacturing, supply chain, logistics, procurement, or sales operations environments. 

• Knowledge of training needs analysis, instructional design, adult learning principles, training evaluation methods, and eLearning development. 

• Demonstrated ability to deliver instructor-led training at a high level. 

• Demonstrated ability to work well in a fast-paced environment. 

• C1 German language skills (written and spoken)