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Quality Control Inspector II, 2nd Shift

Job in NJ New Jersey - USA , 08536
Company: Integra LifeSciences Holdings Corporation
Contract position
Listed on 2021-02-25
Job specializations:
  • Quality Control
    Quality Assurance, QA Specialist
  • Manufacturing
Job Description & How to Apply Below
Position:  Quality Control Inspector II, 2nd Shift (2-10pm)
Location: Plainsboro
Overview

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 pan as per the American national standard institute (ANSI),
* Assist in the review and disposition of non-conforming material and customer returned material, including rework, scrap, and return to vendor.
* Maintain accurate and current inspection and/or testing records such as nit not limited to Material Certifications, Inspection/Test Results and reports, Certificates of Conformance, Rejection reports/tags, as required by applicable procedure and/or specification
* Coordinate and inform other departments of inspection and/or testing status in support of production and project goals and initiatives.
* Promote and participate in continuous improvement initiatives
* Responsible for the maintenance of appropriate conditions of all quarantine locations.
* Maintain the QC inspection areas in an orderly fashion conducive to carrying out safe and efficient inspections and procedures.
* Inspection requirements include training and working in classified clean rooms as necessary to perform in process inspections.
* Maintain records of inspection and all testing performed on the appropriate test records.
* Perform line clearances and quality reviews in manufacturing, labeling, or other assigned areas during manufacturing activities.
* Identify and implement opportunities for continuous improvement, including document revisions in order to maintain accurate SOPs.
* Provide quality support to various departments as needed, e.g. engineering, product development, etc.)
* Assist in training new associates according to the Quality System Regulations and company SOPs as applicable.
* May also perform other related duties, responsibilities, and special projects as assigned

Qualifications

* High School diploma (or GED) and some college level courses
* 2-7 years of relevant GMP/GLP experience specific to incoming, line clearance, in-process, and finished goods inspections in pharmaceutical or medical device industry.
* QA experience in the medical device industry preferred.
* Must have strong written and verbal communication skills.
* Strong organizational skills, self-directed, strong problem solving and interpersonal skills.
* Knowledge of CAPA, Validations, Change Control, preferred.
* Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP.
* Knowledgeable in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) preferred.
* 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, strong time management are essential
* Must be able to work independently with minimal supervision.
Position Requirements
Less than 1 Year work experience
 
 
 
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