QUALITY ENGINEER (217)

Shoolin Inc

Metuchen, NJFull-time$99K/yrSeen todaySeen in employer's feed today

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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 Quality Engineer analyzes product specifications and design changes using quality and risk-management methods, develops approaches based on new Medical Device Regulation requirements, and prepares process-flow, control, inspection, and validation documents. The role also implements corrective and preventive actions to address nonconformance, tests prototype devices, and prepares reports. A master's degree in a listed science, technology, engineering, or biotechnology field is required.

Skills & qualifications

RequiredNice to have

Skills

CAPASix SigmaFMEADFMEAPFMEAIQOQPQKaizenMedical Device Regulation

Qualifications

Master's in Listed Fields

Full job description

Minimum Education Required

Masters

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.

Email Resume to HR Dept., Shoolin, Inc., at [email protected]