Quality Inspector

## Quality Inspector IApplylocations:
US-NJ-Plainsboro-105-Facility time type:
Full time posted on:
Posted Yesterday job requisition :
JR-5786

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
** SUMMARY DESCRIPTION
** 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 to 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.
** Position is a 4 day/10hour shift (M-TH)
**** ESSENTIAL DUTIES AND 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.# DESIRED MINIMUM QUALIFICATIONS
* High School Diploma.
* QA experience in the medical device industry preferred.
* Strong organizational skills, self-directed, strong problem solving and interpersonal skills.
* Working knowledge of ISO 13485, 21

CFR
820 FDA QSR, and cGMP preferred.
* 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 and strong time management are essential.
* Must be able to work independently with minimal supervision.

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, and write in English.  The employee…