Quality Inspector I, 2nd Shift

Integra LifeSciences•Plainsboro Township, NJ

2d•$19 - $25•Onsite

About The Position

The Quality Inspector I will be responsible for performing quality assurance inspections on purchased components, manufactured sub-assemblies and final product. The Quality Inspector will perform all duties in accordance with the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies. Expectations are to be familiar with and able to measure critical dimensions.

Requirements

High School Diploma.
Ability to define problems, collect data, establish facts and draw valid conclusions.
Ability to work effectively in a cross functional environment.
Ability to integrate quality objectives across multiple functions.
Attention to detail and strong time management are essential.
Must be able to work independently with minimal supervision.
Repeatedly sit, listen, speak, and write in English.
Go to all areas of the company.
Enter cleanrooms while adhering to Standard Operating procedures.
Pass a visual acuity test. Vision aids, such as glasses or contact lenses, are allowed and must be worn during visual inspections if needed to pass the test.

Nice To Haves

QA experience in the medical device industry preferred.
Strong organizational skills, self-directed, strong problem solving and interpersonal skills.
Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP preferred.
Knowledgeable in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) preferred.

Responsibilities

Perform inspection by using a variety of inspection measuring and test equipment to determine acceptance or rejection of material or parts.
Perform first article, incoming/receiving, and in-process inspections of materials or parts; determine acceptance or rejection after inspection and/or testing of materials, parts, and/or equipment.
Interpret and work within the guideline of drawings, specifications, charts, procedures, and other data to determine acceptance or rejection of materials.
Read and interpret sampling plan as per the American national standard institute (ANSI).
Assist in training new associates according to the Quality System Regulations and company SOPs as applicable.
Maintain accurate and current inspection and/or testing records such as and not limited to Material Certifications, Inspection/Test Results and reports, Certificates of Conformance, Rejection reports/tags, as required by applicable procedure and/or specification.
Assist with reviewing inspection reports, completed Quality forms, logbooks, and associated Quality forms.
Inspection requirements include training and working in classified clean rooms as necessary to perform in process inspections.
Perform line clearances and quality reviews in manufacturing, labeling, or other assigned areas during manufacturing activities.
Maintain records of inspection and all testing performed on the appropriate test records.
Assist in physical moving and labeling of non-conforming material and customer returned material, including rework, scrap, and return to vendor.
Maintain the QC inspection areas in an orderly fashion conducive to carrying out safe and efficient inspections and procedures.
May also perform other related duties, responsibilities, and special projects as assigned.