QUALITY ENGINEERS #595

Kennedy International Software Inc

Metuchen, NJFull-time$99K/yrSeen 1w agoSeen in employer's feed 3 days ago

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At a glance

Compensation

$99K/yr

Location

Metuchen, NJ

Schedule

Full-time

Work Authorization

Not specified

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Requirements

Credentials this posting asks for.

Master's degree

Job overview

The role analyzes product specifications and designs changes using CAPA, Six Sigma, FMEA, and related methodologies, develops approaches based on new Medical Device Regulation requirements, prepares design and validation documents, implements CAPA actions, tests prototype devices and prepares reports.

Skills & qualifications

RequiredNice to have

Skills

CAPASix SigmaFMEADFMEAPFMEAIQOQPQKaizenMedical Device RegulationDesign Process FlowControl PlanInspection PlanValidation DocumentsPrototype Testing

Qualifications

Master's Degree

Full job description

Minimum Education Required

Master's degree

Compensation

$98,571.00 - $98,571.00 / Yearly

Hours Per Week

Number Of Positions

Shift

First Shift (Day)

Job Description

Analyze product specifications and design changes using CAPA, Six Sigma, FMEA, DFMEA & PFMEA, IQ, OQ, PQ and Kaizen. Develop approaches and methodologies based on new Medical Device Regulation requirements. Prepare design process flow, control plan, inspection plan and validation documents. Implement CAPA actions to prevent nonconformance relating to the product, process, and operating standards. Test prototype devices and prepare reports. Master’s degree in Science, Technology, Engineering, Mechanical Engineering, Industrial Engineering, or Biotechnology Engineering (any) is required. Work location: Metuchen, NJ and various unanticipated locations throughout the U.S.