Job DescriptionEssential Duties & Responsibilities - Work closely with Quality to resolve CAPA (Corrective and Preventive Action) Life Cycle Management, including root cause investigation, resolution planning, implementation and closure.
- Support Field Service through the development of quality procedures and tools, writing, updating and organizing department BOPs from a quality perspective, providing support in remediation efforts and training.
- Be the communications focal point for the Field Service department in matters regarding quality support.
- Perform Compliance Audits on Field Service Engineers (FSEs)
- Provide quality assessments, performance summaries, administrative reports, and feedback regarding Field Service product issues, progress, plans, customer visits, field level device repair, remediation, spare parts, upgrades, etc. and distribute recommendations, improvements and training to field service engineers and management team as appropriate.
- Ensure compliance with the Quality organization and processes and maintain this compliance through the administration and use of reports and audits
- Perform periodic spare part cycle counts for the field service team.
- Be the focal point for any inventory adjustments.
- Lead the Field Training team, creating training plans for the National Meeting as well as individual and new employee training.
- Twice yearly perform a customer feedback exercise providing data to individual FSEs and their managers.
Knowledge, Skills & Qualifications - Strong cGMP, process and product knowledge
- Excellent verbal and written communication skills
- Solid computer skills including MS Word, Excel, Visio, PowerPoint and be familiar with networked equipment
- Experience with programmable medical devices and software based medical systems
- Ability to research, learn and become proficient with new technologies and extend that learning to ICU's advantage.
Education and Experience - Associate's degree in technical discipline
- Bachelor's Degree in technical discipline or a combined total of 6 years' experience as a Senior FSE or FSE Manager
Minimum Qualifications - Must be at least 18 years of age
- Must pass pre-employment drug screen and background check
Travel/Vehicle/Credit Requirements - Typically requires travel less than 5% of the time
- Ability to use commercial air travel when necessary
- Periodic travel on short notice
- Valid driver's license
- Must be eligible for the corporate credit card
Physical Requirements and Work Environment - Must be willing to work in a hospital environment, typically a Biomed work area
About UsICU 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.
This role is based remotely; the incumbent may be remote in any state other than Colorado; California; Connecticut; Montana, Maine or New York.
ICU Medical EEO Statement:ICU Medical is committed to being an 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, 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 We are committed to providing equal access and opportunities for all candidates.
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