Compliance Training Supervisor at ICU Medical, Inc. in Austin, Texas

Job Description:

Job Description



FLSA Status: Exempt


Mon-Fri 7:30a-4:30 pm with flexibility for extended hours as needed



Position Summary:

Supervise all shifts of the Compliance Training Department (personnel and daily activities). Subject Mater Expert (SME) and system owner for Training Compliance, iLearning, and integration of the iLearning Learning Management System (LMS). Responsible for the identification, development and implementation of site compliance training needs. Develop and conduct training required for new and existing employees to ensure compliance with policies, procedures, and Current Good Manufacturing Practices (cGMPs). Instructional responsibilities include creation and facilitation of employee development courses. Analyze, report, and troubleshoot employee training records via LMS.


Essential Duties & Responsibilities:

•Create and facilitate the development of training modules beyond read/understand using proven training techniques.
•Ensure iLearning curricula and matrices are set up and maintained in a manner that iLearning can be used as both a training tracking system and a personnel development tool.
•Develop proficiency / qualification testing of key facets for the site including iLearning Knowledge Assessment Tools.
•Coordinate and conduct new employee orientation, facilitation skills, train-the-trainer sessions, and other classroom training as needed.
•Develop and train compliance training staff to ensure they possess skills necessary to effectively support site training needs.
•Ensures Training Compliance associated with Change Controls and Document Revisions are completed.
•Maintain awareness of plant programs/processes, and develop, implement, and continuously improve training documentation to ensure regulatory compliance guidelines are met.
•Perform investigations of training-related cGMP/regulation violations, Investigations, and Corrective and Preventative Actions (CA/PAs).
•Other training project responsibilities as required by corporate or regulatory response to evolving regulatory requirement as assigned by area management.
•Report training status metrics for monthly Management Review.
•Perform other related duties as assigned or required.


Knowledge, Skills & Qualifications:

•Experience with iLearning or other LMS including training record analysis and reporting.
•Advanced Microsoft Office skills, specifically Microsoft Excel and Power Point.
•Effective written and oral communication skills and technical writing skills.
•Strong analytical skills including critical thinking skills to improve existing training systems/processes.
•Must take initiative and be responsible for projects with minimal management direction.
•Demonstrated experience with creating web-based learning, developing, and implementing training materials with proficiency measurements.
•Must be organized to work within numerous systems and programs.
•Regulatory inspection experience discussing training is preferred.
•Specific skills of Public Speaking / Facilitation, Project Management, and situational leadership are preferred.


Education and Experience:

•Must be at least 18 years of age
•Bachelor's degree from an accredited college or university is required.
•4 years of training experience required, preferably in an FDA or similarly regulated industry. Previous supervisory experience is also strongly preferred.


Physical Requirements and Work Environment:

•This is largely a sedentary role.
•This job operates in a professional office environment and routinely uses standard office equipment.
•Typically requires travel less than 5% of the time



About Us



ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.


With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.


We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:

• Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
• The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
• IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
• Significant US IV solutions manufacturing and supply capabilities.

ICU Medical EEO Statement:


ICU Medical is committed to fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and Equal Opportunity Employer, we ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender identity, gender expression, gender reassignment, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.


If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.


ICU Medical EEO Policy Statement



OFCCP Equal Opportunity Posters

"Know Your Rights" Poster
Pay Transparency Nondiscrimination Provision


ICU Medical CCPA Notice to Job Applicants Apply Now