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Intellectt Inc

Iselin, NJFull-time$130K/yrSeen todaySeen in employer's feed today

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At a glance

Compensation

$130K/yr

Location

Iselin, NJ

Schedule

Full-time

Work Authorization

Not specified

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Requirements

Credentials this posting asks for.

Bachelor's degree

Job overview

Work on product performance specifications and design changes. Create and update Failure Mode and Effects Analysis for new implants and instruments. Implement CAPA actions to prevent nonconformance. Develop approaches based on new Medical Device Regulation requirements. Perform internal audits supporting ISO standards.

Skills & qualifications

RequiredNice to have

Skills

CAPASix SigmaGap AnalysisISO 9001ISO 13485FMEADFMEAPFMEADOEIQOQPQKaizen

Qualifications

Bachelor's Degree in Science, Technology, Engineering, Mechanical Engineering, Industrial Engineering, Biotechnology EngineeringFive Years Experience

Full job description

Experience Required

60 MONTHS

Minimum Education Required

BACHELOR'S DEGREE

Compensation

$130,499.00 - $130,499.00 / Yearly

Hours Per Week

Number Of Positions

Shift

First Shift (Day)

Job Description

Work on product performance specifications and design changes. Create, and update Failure Mode and Effects Analysis (DFMEA) for new implants and instruments. Implement CAPA actions to prevent nonconformance relating to the product, process, and operating standards. Develop Approaches and methodologies based on new Medical Device Regulation requirements. Perform internal audits in support of ISO standards. Skills required: CAPA, Six Sigma, Gap Analysis, ISO 9001, ISO 13485, FMEA, DFMEA & PFMEA, DOE, IQ, OQ, PQ, and Kaizen. Bachelor’s degree in Science, Technology, Engineering, Mechanical Engineering, Industrial Engineering, or Biotechnology Engineering (any) along with five (05) years of experience in the job offered or related occupation is required. Work location: Iselin, NJ and various unanticipated locations throughout the U.S.

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