A global medical device company and a leader in new product development and medical education in orthopedics. Company is actively seeking a Sr QMS Technical Training & Competency – Training Specialist who works directly with the Quality & Regulatory departments within Arthrex. The QMS Technical Training & Competency Specialist position works with all departments (US and Global) to ensure QMS technical training requirements are identified, implemented, and maintained in accordance with the requirements of all applicable regulatory requirements including, but not limited to, 21 CFR 820 and ISO 13485:2016. Position is responsible for the design, development, sourcing, implementation, and evaluation of technical and competency training programs. Excellent communications and analytical skills, strong Technical Training & Instructional Design skills and a Bachelors’ degree will be essential for this position. J
This is an in-office position located in Naples, Florida; it is not a remote position.
Essential Duties and Responsibilities:
- Evaluates QMS processes and procedures and works with subject matter experts across the organization to determine training needs, curriculum requirements and technical and competency training requirements.
- Provide LMS support including daily administration, inquiries, creating courses and assessments, tracking, escalations, reporting, and record keeping.
- Develop competency-based training content and curriculum structure to meet identified training needs.
- Evaluates quality systems training programs to ensure materials are instructionally sound and effective for intended audience and training solution.
- Act as instructional designer in design and development of new in-house quality systems focused training programs working with subject matter experts to ensure valid content and effective delivery method, assessing, and providing direction to training providers as necessary.
- Conduct and present internal training programs as necessary.
- Evaluate the effectiveness of training and utilize results for continuous improvement.
- Evaluate and recommend new tools, techniques, and delivery platforms for training.
- Delivers train-the-trainer programs for technical and production trainers as identified throughout the organization.
- Create & review related Quality Systems documents as needed.
- Reviews and updates existing training materials as required.
- May lead other employees.
Education and Experience:
- Bachelor’s degree required, preferably in Training, Learning Development or related field.
- 5 years of training/operations experience required
- Previous experience or exposure to medical device manufacturing processes, written procedures and data collection/reporting required
- Experience in development and application of Adult Learning Principles
- Experience in instructional design methodologies for QMS training content
- Previous experience with role-based curriculum development and training material development in a medical device industry.
- Experience with varied learning management systems a plus
- Up to 15% Travel
Knowledge and Skill Requirements/Specialized Courses and/or Training:
- Strong oral and written communications skills and the ability to develop and maintain business/technical documentation is required
- Ability to assume responsibility and work autonomously or collaboratively in a professional and timely manner.
- Must have advanced organizational skills and the ability to manage multiple priorities.
- Ability to adapt to new technologies and a rapidly changing environment.
- Competent in handling multiple tasks with attention to detail and perform duties with minimal supervision.
- High level of diplomacy and ability to relate and interact with personnel at all levels.
Machine, Tools, and/or Equipment Skills:
PCs, Microsoft Office/Windows, databases, ERP systems, Document Management Systems, Learning Management Systems