ICU Medical Job - 49020703 | CareerArc
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Company: ICU Medical
Location: Dublin, OH
Career Level: Entry Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

FLSA Status

Non-Exempt

Standard Job Title

Inspector I, Quality

Work Schedule

Monday- Friday

6:00AM- 3:00PM

 

Position Summary  

In this role employee will perform entry level inspection, repetitive tasks associated with visual inspections and basic functional testing knowledge. Responsible for ensuring company products are in compliance with internal and external specifications by performing a variety of routine and non-routine inspections and evaluations. Ability to perform inspection tasks use microscopes, calipers, and micrometers.

 

Essential Duties & Responsibilities 

·         Perform accurate mechanical, physical, and visual inspections of raw materials, components, and sub-assemblies as per inspection plans and specification requirements.

·         Perform PCI activities for NA Notifications at the US Regional Service Center as needed.

·     Follows all procedural requirements in the area of responsibility in order to maintain compliance to applicable Quality System Regulations (i.e cGMP compliance).

·         Supports the paper document archival process including preparation of pallets for shipment.

·         Initiate Non-Conformance reports as required.

·         Supports NC and CAPA activities as needed.

·         Work on special projects as assigned.

Knowledge, Skills & Qualifications 

  •          Minimum HS graduate or GED equivalent.
  •          Technical Degree preferred.  
  •          Must have basic computer skills to regularly access and document information in a computer.
  •          Must have basic written and oral communication skills adequate to communicate with other team members, understand verbal instructions, read, and comprehend written work instructions including words and engineering drawings.
  •          Demonstrated knowledge with medical device regulations and FDA regulatory standards preferred. 

 

Education and Experience  

·         High School Diploma is required. 

 

Minimum Qualifications 

·         Must be at least 18 years of age. 

 

Travel Requirements  

·         Typically requires travel less than 5% of the time. 

 

Physical Requirements and Work Environment  

·         Must be able to perform essential job functions in an office 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.

 

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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