About this role
Work Flexibility: Hybrid
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
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- 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)
Travel Percentage: 10%