Quality Validation Engineer - NPI

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:text,ActualValueFromSolar:null},{QuestionName:Job Description,AnswerValue:u003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003e**MEMBERS ONLY**SIGN UP NOW***. LLC is seeking a u003cSTRONGu003eQuality Validation Engineer u003c/STRONGu003eu0026nbsp;to support new product introductions, provide statistical, documentation and coordination support to ensure objectives are met throughout the entire IQ, OQ, PQ Validation process.u003c/FONTu003eu003c/FONTu003eu003cBRu003eu003cBRu003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eu003cSTRONGu003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eEssential Functions:u003c/FONTu003eu003c/STRONGu003eu003c/FONTu003eu003c/FONTu003eu003cBRu003eu0026nbsp;u003cUL dir=ltru003eu003cLI style=LINE-HEIGHT: normal\u003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eDrafting Validation documents including FAT, SAT, IQ, OQ, PQ, PPQ and URSu003c/FONTu003eu003c/FONTu003eu003c/LIu003eu003cLI style=LINE-HEIGHT: normal\u003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eDraft Validation reports and review attachments including Device History Recordsu003c/FONTu003eu003c/FONTu003eu003c/LIu003eu003cLI style=LINE-HEIGHT: normal\u003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eCreate and revise Device Master Record documentsu003c/FONTu003eu003c/FONTu003eu003c/LIu003eu003cLI style=LINE-HEIGHT: normal\u003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eDevelopment and implementation of statistical incoming and in-process sampling/control plansu003c/FONTu003eu003c/FONTu003eu003c/LIu003eu003cLI style=TEXT-ALIGN: justify\u003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eUse statistics to assess product performance data, solve complex manufacturing quality problems and support validation strategies (Cpk, SPC, t-tests, OC Curves, sample size, Minitab).u003c/FONTu003eu003c/FONTu003eu003c/LIu003eu003cLI style=TEXT-ALIGN: justify\u003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eParticipate in initial process development, Design for Manufacturing and Design for Assembly phases.u003cSPAN style=BACKGROUND: white\u003e Develops validation templates.u003c/SPANu003eu003c/FONTu003eu003c/FONTu003eu003c/LIu003eu003cLI style=TEXT-ALIGN: justify\u003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eInterfaces with engineering, operations, customer, and vendor representatives to ensure all requirements are met. u003c/FONTu003eu003c/FONTu003eu003c/LIu003eu003cLI style=LINE-HEIGHT: normal\u003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eSubmit Metrology requests and analyze datau003c/FONTu003eu003c/FONTu003eu003c/LIu003eu003cLI style=LINE-HEIGHT: normal\u003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eFacilitate meetings for PFMEAs and Control Plansu003c/FONTu003eu003c/FONTu003eu003c/LIu003eu003cLI style=LINE-HEIGHT: normal\u003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eProvide training to production staff on validated work instructionsu003c/FONTu003eu003c/FONTu003eu003c/LIu003eu003cLI style=LINE-HEIGHT: normal\u003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eProvide updates on project status and support team meetings with customersu003c/FONTu003eu003c/FONTu003eu003c/LIu003eu003cLI style=LINE-HEIGHT: normal\u003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eAssist with third party and FDA quality audits as needed.u003c/FONTu003eu003c/FONTu003eu003c/LIu003eu003c/ULu003e,VerityZone:jobdescription,QuestionType:textarea,ActualValueFromSolar:null},{QuestionName:Job Number,AnswerValue:11025BR,VerityZone:autoreq,QuestionType:text,ActualValueFromSolar:null},{QuestionName:Job Category,AnswerValue:Engineering, Manufacturing / Production / Operations, Quality Assurance / Safety,VerityZone:formtext2,QuestionType:multi-select,ActualValueFromSolar:null},{QuestionName:Position Qualifications,AnswerValue:u003cSTRONGu003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eRequired Qualifications, Skills and Abilities include:u003c/FONTu003eu003c/FONTu003eu003c/STRONGu003eu003cBRu003eu0026nbsp;u003cUL dir=ltru003eu003cLIu003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eBachelor’s Degree in an engineering discipline or equivalent experience or Certificationu003c/FONTu003eu003c/FONTu003eu003c/LIu003eu003cLIu003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003e6 years quality/regulatory experienceu003c/FONTu003eu003c/FONTu003eu003c/LIu003eu003cLIu003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003e3 years auditing experienceu003c/FONTu003eu003c/FONTu003eu003c/LIu003eu003cLIu003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eThorough knowledge of CFR 21, Part 820, ISO 13485:2016u003c/FONTu003eu003c/FONTu003eu003c/LIu003eu003cLIu003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eClear and concise verbal, written and presentation skillsu003c/FONTu003eu003c/FONTu003eu003c/LIu003eu003cLIu003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eAbility to identify problems, and develop and implement actions to resolve themu003c/FONTu003eu003c/FONTu003eu003c/LIu003eu003cLIu003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eDemonstrable track record of planning activities with contingency actionsu003c/FONTu003eu003c/FONTu003eu003c/LIu003eu003c/ULu003eu0026nbsp;u003cBRu003eu0026nbsp;u003cBRu003eu003cSTRONGu003eu003cEMu003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eThis position does not qualify for VISA sponsorshipu003c/FONTu003eu003c/FONTu003eu003c/EMu003eu003c/STRONGu003eu003cBRu003eu0026nbsp;u003cBRu003eu003cSTRONGu003eu003cEMu003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eAbout **MEMBERS ONLY**SIGN UP NOW***., LLC…u003c/FONTu003eu003c/FONTu003eu003c/EMu003eu003c/STRONGu003eu0026nbsp;u003cBRu003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003e**MEMBERS ONLY**SIGN UP NOW***., LLC, a Molex company, is a leading global outsource provider of design and manufacturing services to the drug delivery, consumable diagnostics, medical device and specialty commercial markets.u003c/FONTu003eu003c/FONTu003eu003cBRu003eu0026nbsp;u003cBRu003eu003cSTRONGu003eu003cEMu003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eLearn more...u003c/FONTu003eu003c/FONTu003eu003c/EMu003eu003c/STRONGu003eu003cBRu003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eVisit us: u003c/FONTu003eu003c/FONTu003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eu003cA tabIndex=1000 href=****style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eTwitter: u003c/FONTu003eu003c/FONTu003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eu003cA tabIndex=1000 href=****style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eYouTube: u003c/FONTu003eu003c/FONTu003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eu003cA tabIndex=1000 href=****style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eLinkedin: u003c/FONTu003eu003c/FONTu003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eu003cA tabIndex=1000 href=****style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003e**MEMBERS ONLY**SIGN UP NOW***. History: u003c/FONTu003eu003c/FONTu003eu003cFONT style=FONT-SIZE: 10pt\u003eu003cFONT style=FONT-FAMILY: tahoma, sans-serif; size: undefined\u003eu003cA tabIndex=1000 href=****MA 01510 ,VerityZone:formtext8,QuestionType:single-select,ActualValueFromSolar:null},{QuestionName:**MEMBERS ONLY**SIGN UP NOW***. is an affirmative action/equal opportunity employer.,AnswerValue:This employer uses E-Verify. 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