Description
FLSA Status: Non-Exempt
Position Summary:
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
•Must be at least 18 years of age
•HS Diploma or Equivalent
•Minimum of 2+ Years in a similar quality function working with Medical Devices
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.
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