Quality Inspector I-Weekend 4th Shift

Smiths Medical; Southington (CT); On-site; USD 35,000 - 50,000; Full time

Job summary

A leading company seeks a quality inspector in Southington, CT, to ensure compliance through inspections and quality management. Key tasks include monitoring quality standards, documenting findings, and supporting regulatory requirements. Ideal candidates possess strong communication skills and a foundational understanding of medical device regulations.

Qualifications

• High School graduate or GED, AA or Technical Degree preferred.
• Must be at least 18 years old.
• Demonstrated knowledge of FDA regulations preferred.

Responsibilities

• Perform mechanical, physical and visual inspections of materials.
• Support compliance with Quality System Regulations and cGMP.
• Participate in Non-Conformance reports and CAPA activities.

Skills

Basic computer skills

Written communication

Oral communication

Inspection tasks knowledge

Knowledge of medical device regulations

Education

High School diploma or GED

AA or Technical Degree

Tools

Microscope

Calipers

Micrometers

Job 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.