Position Summary
The Inspector II will perform moderately complex, repetitive tasks associated with quality inspections. The incumbent will ensure company products are in compliance with internal and external specifications by performing a variety of routine and non-routine inspections and evaluations.
Essential Duties & Responsibilities
- Perform accurate mechanical, physical and visual inspections of raw materials, components, and sub-assemblies as per inspection plans and specification requirements.
- Observe, measure and record data. Report discrepancies.
- Audit manufacturing processes, subassemblies and finished product to assure compliance with established specifications.
- Compare inspection results to defined requirements or specifications and document differences found.
- Follow all procedural requirements in the area of responsibility in order to maintain compliance to applicable Quality System Regulations (i.e.: cGMP compliance).
- Support the paper document archival process including preparation of pallets for shipment as well as the scanning of Documents for electronic archival in Agile.
- Provide training/support for Inspector I personnel as required.
- Initiate Non-Conformance reports as required.
- Support NC and CAPA activities as needed.
- Work on special projects as they may arise.
Knowledge and Skills
- Strong computer skills to regularly access and document information.
- Written and oral communication skills for communication with other team members, understanding of verbal instructions, and reading/comprehension of written work instructions including words and engineering drawings.
- Demonstrated knowledge of medical device regulations and FDA regulatory standards preferred.
- Attention to detail and a high level of accuracy are essential.
Minimum Qualifications, Education and Experience
- High School graduate or GED equivalent. AA or Technical Degree preferred.
- Minimum of 2+ years of experience required.
- Must be at least 18 years of age
Work Environment
- Must be able to perform essential job functions in an office environment.
- Work is also performed in a clean room environment.
- Long periods of sitting to enter/analyze data is expected.
- Must have adequate manual dexterity to operate standard office equipment
- Must be able to occasionally lift objects up to 25 lbs.
- Typically requires travel less than 5% of the time
Company
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 [email protected]. We are committed to providing equal access and opportunities for all candidates.