Quality Inspector I

ICU Medical • Southington, CT

10h

About The Position

Description Essential Duties & Responsibilities Perform accurate mechanical, physical and visual inspections of raw materials, components, and sub-assemblies as per inspection plans and specification requirements. 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 as well as the scanning of Documents for electronic archival. Initiate Non-Conformance reports as required. Supports NC and CAPA activities as needed. Work on special projects as they may arise. Knowledge and Skills Basic computer skills in order to regularly access and document information. Must have basic written and oral communication skills adequate to communicate with other team members, understand verbal instructions, and read and comprehend written work instructions including words and engineering drawings. Ability to perform inspection tasks using microscopes, calipers and micrometers. Ability to complete 10-15 inspections. Demonstrated knowledge of medical device regulations and FDA regulatory standards preferred. Minimum Qualifications, Education and Experience High School graduate or GED equivalent. AA or Technical Degree preferred. Must be 18 years of age. 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. Typically requires travel less than 5% of the time.

Requirements

• Basic computer skills in order to regularly access and document information.
• Must have basic written and oral communication skills adequate to communicate with other team members, understand verbal instructions, and read and comprehend written work instructions including words and engineering drawings.
• Ability to perform inspection tasks using microscopes, calipers and micrometers. Ability to complete 10-15 inspections.
• High School graduate or GED equivalent.
• Must be 18 years of age.
• 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.

Nice To Haves

• AA or Technical Degree preferred.
• Demonstrated knowledge of medical device regulations and FDA regulatory standards preferred.

Responsibilities

• Perform accurate mechanical, physical and visual inspections of raw materials, components, and sub-assemblies as per inspection plans and specification requirements.
• 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 as well as the scanning of Documents for electronic archival.
• Initiate Non-Conformance reports as required.
• Supports NC and CAPA activities as needed.
• Work on special projects as they may arise.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED