Inspector I
ICU Medical · Southington, CT · 3 mo ago
On-siteEngineeringFull-time
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
- A High School graduate or GED equivalent.
- An AA or Technical Degree preferred.
- Must be 18 years of age.