Job Description

This job will support complaint investigation for ICU manufactured/marketed Medical Devices. This position will catalog returned products with the registered complaint, photograph devices “as received”, decontaminate used devices, and document initial visual assessment in complaint database. Position will work directly with Quality Engineers to aide in the investigation process.

Essential Duties & Responsibilities

• Must be willing to work with used, therefore contaminated medical devices.
• Ensures proper documentation and registration of returned complaint devices.
• Ability to write effective reports on initial investigation of returned devices
• Basic trouble shooting and root cause analysis
• Ability to effectively and professionally communicate with internal and external customers (as required).
• Ability to perform basic product testing (i.e. leak tests, flow tests, basic measurements)
• Work closely with and take direction from Quality Engineers to aid in the investigation process of returned devices
• Follow cGMP
• Must be detail oriented and highly organized
• Other duties as assigned
• Work on special projects as they arise

Knowledge, Skills & Qualifications

• Ability to read product specifications and test procedures
• cGMP knowledge
• Basic math skills
• Microsoft Office and computer knowledge (Trackwise experience a plus)
• Strong verbal and written communication skills

Education and Experience

HS Diploma or Equivalent

Minimum of 2+ Years in a similar quality function working with Medical Devices

Minimum Qualifications

• Must be at least 18 years of age

Physical Requirements and Work Environment

Work is generally performed in a demanding fast paced environment in which priorities and instruction can shift daily. While performing the duties of this job the employee is will be handling used and contaminated medical devices in a controlled environment. Work schedule hours may change based on returned product quantities or shifting priorities. Must be able to lift up to 30lbs and work on feet 80% of the day.

ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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 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 humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.