QUALITY ENGINEERS

PREMIER LIFE SCIENCES, LLC

South Plainfield, NJFull-time$99K/yrSeen 1mo agoSeen in employer's feed 2 days ago

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At a glance

Compensation

$99K/yr

Location

South Plainfield, NJ

Schedule

Full-time

Work Authorization

Not specified

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Requirements

Credentials this posting asks for.

Master's degree

Job overview

The Quality Engineer 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 Regulation

Qualifications

Master's Degree in Science, Technology, Engineering, Mechanical Engineering, Industrial Engineering, or Biotechnology Engineering

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: South Plainfield, NJ and various unanticipated locations throughout the U.S.

Email Resume to HR Dept., Premier Life Sciences, LLC., at [email protected].