Quality Inspector

ARCH•Seabrook, NH

8d•Onsite

About The Position

The Quality Inspector will perform mechanical inspection of raw materials and purchased parts using basic gages. This role involves verifying the accuracy and completeness of data and certificates of conformance, resolving discrepancies with purchasing, and ensuring parts are procured from approved suppliers. The inspector will document inspection results, conduct Device History Record reviews, and review completed work orders and product documentation for accuracy. A key responsibility is the visual inspection of parts before packaging. The role requires working independently with minimal supervision, following established work queues, and meeting productivity and quality standards. The Quality Inspector will support and ensure compliance with FDA and ISO13485 Quality Management Systems and may assist with other manufacturing operations as needed.

Requirements

High School Diploma or GED required
Minimum of 1-2 years working in a Manufacturing environment
Proficient with hand gages include but not limited to calipers, thread gages, micrometer, and pin gages.
Basic blueprint reading and shop math.
Strong analytical skills and the ability to express concepts effectively.
Strong computer skills.
Strong interpersonal skills including, but not limited to, contributing to a team-oriented environment, balancing team and individual responsibilities, and keeping emotions under control.
Must have vision acuity of 20/30 or better in either eye and shall be able to read the Jaeger No.2 Eye Chart at 16 in. Natural or corrected vision may be used to achieve eye test requirements.
Familiar with Word, Excel, and ERP systems

Responsibilities

Perform mechanical inspection of raw materials and purchased parts using basic gages such as calipers, micrometers, pin gages, and thread gages.
Verify that data and certificate of conformance provided with purchased parts and materials are accurate and complete.
Work with purchasing to resolve any discrepancies.
Assure that parts are procured from supplier who is on the approved supplier list.
Documents inspection results by completing reports and logs in Quality Management Software.
Conduct Device History Record review per established procedures.
Review completed work orders, product documentations, test and inspection data to ensure entries are complete, accurate, and legible.
Conduct visual inspection of parts prior to release to packaging.
Work independently with minimal supervision.
Follow established queues for order of work to be performed.
Meet established standards for productivity and quality.
Confer with supervisor when problems arise which impact expected level of performance.
Responsible for supporting and ensuring compliance to FDA and ISO13485 Quality Management System in areas of responsibility.
Assist with other manufacturing operations as needed to meet business needs.