Senior Quality Engineer

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:text,ActualValueFromSolar:null},{QuestionName:Job Description,AnswerValue:u003cstrongu003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003ePosition Overview: u003c/fontu003eu003c/fontu003eu003c/strongu003eu003cbru003eu003cspan style=background: white;\u003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eu003cspan style=color: rgb(18, 18, 18);\u003e**MEMBERS ONLY**SIGN UP NOW***. Costa Mesau003c/spanu003eu003c/fontu003eu003c/fontu003eu003c/spanu003eu003cspan style=background: white; color: rgb(18, 18, 18); line-height: 107%; font-family: tahoma,sans-serif;=\ font-size:=\ 10pt;=\ mso-fareast-font-family:=\ times=\ new=\ roman;=\ mso-ansi-language:=\ en-us;=\ mso-fareast-language:=\ mso-bidi-language:=\ ar-sa;=\u003e is seeking a Senior Quality Engineer tou0026nbsp;lead and coordinate CAPA and customer complaints processes, support all aspects of QMS and manage customer interactions related to medical device manufacturing quality.u0026nbsp;u003c/spanu003eu003cbru003eu003cbru003eu003cstrongu003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma,sans-serif; size: undefined;\u003eu003cspan style=color: rgb(51, 51, 51);\u003eEssential Functions:u003c/spanu003eu003c/fontu003eu003c/fontu003eu003c/strongu003eu0026nbsp;u003cbru003eu0026nbsp;u003cul dir=ltr\u003eu003cli style=color: rgb(34, 34, 34); line-height: normal;\u003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma,sans-serif; size: undefined;\u003eFacilitate meetings with the customers to ensure alignment on new product introduction and resolution of sustaining product issues.u003c/fontu003eu003c/fontu003eu003c/liu003eu003cli style=color: rgb(34, 34, 34); line-height: normal;\u003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma,sans-serif; size: undefined;\u003eLead or support during regulatory, ISO and customer audits. u003c/fontu003eu003c/fontu003eu003c/liu003eu003cli style=color: rgb(34, 34, 34); line-height: normal;\u003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma,sans-serif; size: undefined;\u003eProvide guidance and training to employees as related to QMS compliance.u003c/fontu003eu003c/fontu003eu003c/liu003eu003cli style=color: rgb(34, 34, 34); line-height: normal;\u003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma,sans-serif; size: undefined;\u003eFollow up on quality issues and ensure appropriate responses.u003c/fontu003eu003c/fontu003eu003c/liu003eu003cli style=color: rgb(34, 34, 34); line-height: normal;\u003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma,sans-serif; size: undefined;\u003eManage customer complaints and oversee the completion of corrective actions to reduce those risks that are highlighted on the report. u003c/fontu003eu003c/fontu003eu003c/liu003eu003cli style=color: rgb(34, 34, 34); line-height: normal;\u003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma,sans-serif; size: undefined;\u003eProactively monitor and trend customer data.u003c/fontu003eu003c/fontu003eu003c/liu003eu003cli style=color: rgb(34, 34, 34); line-height: normal;\u003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma,sans-serif; size: undefined;\u003eLead and coordinate CAPA and customer complaints processes.u003c/fontu003eu003c/fontu003eu003c/liu003eu003cli style=color: rgb(34, 34, 34); line-height: normal;\u003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma,sans-serif; size: undefined;\u003eConduct root cause analysis and collaborate with other CAPA owners and cross functional team members to develop Investigation plan and adhere to CAPA phase timelines. u003c/fontu003eu003c/fontu003eu003c/liu003eu003cli style=color: rgb(34, 34, 34); line-height: normal;\u003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma,sans-serif; size: undefined;\u003eContinually assess the CAPA system and quality system procedures for continual improvement.u003c/fontu003eu003c/fontu003eu003c/liu003eu003cli style=color: rgb(34, 34, 34); line-height: normal;\u003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma,sans-serif; size: undefined;\u003eCommunicate with Quality Manager on progress and any barriers to achieving the customeru0027s quality goals.u003c/fontu003eu003c/fontu003eu003c/liu003eu003cli style=color: rgb(34, 34, 34); line-height: normal;\u003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma,sans-serif; size: undefined;\u003eReport status of key customer deliverables on a monthly basis.u0026nbsp; u003c/fontu003eu003c/fontu003eu003c/liu003eu003cli style=color: rgb(34, 34, 34); line-height: normal;\u003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma,sans-serif; size: undefined;\u003eCommunicate customeru0027s expectations and changes in requirements to appropriate personnel. u003c/fontu003eu003c/fontu003eu003c/liu003eu003cli style=color: rgb(34, 34, 34); line-height: normal;\u003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma,sans-serif; size: undefined;\u003eProvide support and expertise in the development of FMEAu0027s, Control Plans, Qualification Plans, etc., associated with Customer Quality Assurance.u003c/fontu003eu003c/fontu003eu003c/liu003eu003cli style=color: rgb(34, 34, 34); line-height: normal;\u003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma,sans-serif; size: undefined;\u003eUnderstand, support and contribute to current Total Cost of Quality (TCOQ), QMS and EHu0026amp;S Management Systems by following stated policies and procedures.u003c/fontu003eu003c/fontu003eu003c/liu003eu003cli style=color: rgb(34, 34, 34); line-height: normal;\u003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma,sans-serif; size: undefined;\u003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma,sans-serif; size: undefined;\u003eu003cspan style=color: rgb(34, 34, 34);\u003eOther duties, as assignedu003c/spanu003eu003c/fontu003eu003c/fontu003eu003c/fontu003eu003c/fontu003eu003c/liu003eu003c/ulu003e,VerityZone:jobdescription,QuestionType:textarea,ActualValueFromSolar:null},{QuestionName:Job Number,AnswerValue:11002BR,VerityZone:autoreq,QuestionType:text,ActualValueFromSolar:null},{QuestionName:Job Category,AnswerValue:Biotech/Ru0026D/Science, Electrical Distribution / Industrial Automation, Electronics, 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: u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp; u003c/fontu003eu003c/fontu003eu003c/strongu003eu003cbru003eu0026nbsp;u003cul dir=ltr\u003eu003cliu003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eBachelor’s degree and 5 years’ minimum experience inu0026nbsp;Qualityu0026nbsp;Engineering; OR a Master’s degree with 3 years’ minimum experience inu0026nbsp;Qualityu003c/fontu003eu003c/fontu003eu003cspan style=font-family: Tahoma, Geneva, sans-serif;\u003eu0026nbsp;u003c/spanu003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eEngineering.u003c/fontu003eu003c/fontu003eu003c/liu003eu003cliu003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eMust have regulatory understandingu0026nbsp;u003c/fontu003eu003c/fontu003eu003c/liu003eu003cliu003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eMust have experience in Medical Device industryu003c/fontu003eu003c/fontu003eu003c/liu003eu003cliu003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eMust be a US citizen; unable to provide visa sponsorshipu003c/fontu003eu003c/fontu003eu003c/liu003eu003c/ulu003eu0026nbsp;u003cbru003eu003cstrongu003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eu003cspan style=color: rgb(51, 51, 51);\u003ePreferred Qualifications:u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u0026nbsp;u003c/spanu003eu003c/fontu003eu003c/fontu003eu003c/strongu003eu003cbru003eu0026nbsp;u003cul dir=ltr\u003eu003cliu003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eQuality, ISO, oru0026nbsp;SPC certificationsu003c/fontu003eu003c/fontu003eu003c/liu003eu003cliu003eu003cspan style=background: white;\u003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif;\u003eKnowledge of medical device manufacturing systems and ISO 13485 preferred.u003c/fontu003eu003c/fontu003eu003c/spanu003eu003c/liu003eu003cliu003eu003cspan style=background: white;\u003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif;\u003eStrong working knowledge of FDA and cGMP regulations and documentation practices, including SOP creationu003c/fontu003eu003c/fontu003eu003c/spanu003eu003c/liu003eu003c/ulu003eu0026nbsp;u003cbru003eu003cstrongu003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eu003cspan style=color: rgb(51, 51, 51);\u003eSkills and Abilities: u003c/spanu003eu003c/fontu003eu003c/fontu003eu003c/strongu003eu003cbru003eu0026nbsp;u003cul dir=ltr\u003eu003cliu003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eu003cspan style=color: black;\u003eUnderstanding of the project development process, associated terminology, and quality system requirements. u003c/spanu003eu003c/fontu003eu003c/fontu003eu003cspan style=background: white;\u003eu003cfont style=font-size: 10.5pt;\u003eu003cfont style=font-family: arial, sans-serif; size: undefined;\u003eWorks under only general direction. Independently determines and develops approach to solutions.u003c/fontu003eu003c/fontu003eu003c/spanu003eu003c/liu003eu003cliu003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eu003cspan style=color: black;\u003eAbility to effectively present information and respond to questions from a group of managers, sales, and customersu003c/spanu003eu003c/fontu003eu003c/fontu003eu003c/liu003eu003cliu003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eu003cspan style=color: black;\u003eStrong verbal and written communication, teamwork, and organizational skillsu003c/spanu003eu003c/fontu003eu003c/fontu003eu003c/liu003eu003cliu003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eu003cspan style=color: black;\u003eAbility to identify problems, and develop and implement actions to resolve themu003c/spanu003eu003c/fontu003eu003c/fontu003eu003c/liu003eu003cliu003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eu003cspan style=color: black;\u003eAbility to motivate and influence people to achieve customer satisfactionu003c/spanu003eu003c/fontu003eu003c/fontu003eu003c/liu003eu003cliu003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eu003cspan style=color: black;\u003eDemonstrable track record of project accomplishmentu003c/spanu003eu003c/fontu003eu003c/fontu003eu003c/liu003eu003cliu003eu003cspan style=background: white;\u003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eStrong working knowledge of FDA and cGMP regulations and documentation practices, including SOP creationu003c/fontu003eu003c/fontu003eu003c/spanu003eu003c/liu003eu003cliu003eu003cspan style=background: white;\u003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eFlexible and Able to produce results in a fast paced, collaborative environmentu003c/fontu003eu003c/fontu003eu003c/spanu003eu003c/liu003eu003c/ulu003eu0026nbsp;u003cbru003eu003cdiv align=center dir=ltr style=text-align: center;\u003eu0026nbsp;u003cbru003eu003chr align=center size=2 width=100%\u003eu003c/divu003eu003cstrongu003eu003cemu003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eu003cspan style=color: rgb(51, 51, 51);\u003eAbout **MEMBERS ONLY**SIGN UP NOW***., LLC…u003c/spanu003eu003c/fontu003eu003c/fontu003eu003c/emu003eu003c/strongu003eu0026nbsp;u003cbru003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eu003cspan style=color: rgb(51, 51, 51);\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/spanu003eu003c/fontu003eu003c/fontu003eu003cbru003eu0026nbsp;u003cbru003eu003cstrongu003eu003cemu003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eu003cspan style=color: rgb(51, 51, 51);\u003eLearn more...u003c/spanu003eu003c/fontu003eu003c/fontu003eu003c/emu003eu003c/strongu003eu003cbru003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eu003cspan style=color: rgb(51, 51, 51);\u003eVisit us:u0026nbsp;u003c/spanu003eu003c/fontu003eu003c/fontu003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eu003ca href=****tabindex=1000\u003ewww.phillipsmedisize.comu003c/au003eu003c/fontu003eu003c/fontu003eu003cbru003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eu003cspan style=color: rgb(51, 51, 51);\u003eTwitter:u0026nbsp;u003c/spanu003eu003c/fontu003eu003c/fontu003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eu003ca href=****tabindex=1000\u003e****style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eu003cspan style=color: rgb(51, 51, 51);\u003eYouTube:u0026nbsp;u003c/spanu003eu003c/fontu003eu003c/fontu003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; 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History:u0026nbsp;u003c/spanu003eu003c/fontu003eu003c/fontu003eu003cfont style=font-size: 10pt;\u003eu003cfont style=font-family: tahoma, sans-serif; size: undefined;\u003eu003ca href=****tabindex=1000\u003e****Mesa, CA 92626 ,VerityZone:formtext8,QuestionType:single-select,ActualValueFromSolar:null},{QuestionName:**MEMBERS ONLY**SIGN UP NOW***. is an affirmative action/equal opportunity employer.,AnswerValue:Except where prohibited by state law, all offers of employment are conditioned upon successfully passing a drug test.u003cbru003e This employer uses E-Verify. Please visit the following website for additional information: u003ca href=****Quality Engineer,JobSiteId:5236,Link:****{Responsive_AdvancedCSS: \,Responsive_BackgroundColor: #ffffff,Responsive_BackgroundImage: ****#333333,Responsive_BaseFontFamily: \u0027Helvetica Neueu0027, Helvetica, Arial, sans-serif,Responsive_BaseFontSize: 16px,Responsive_ButtonBackgroundColor: #005288,Responsive_CompiledCSS: /* remember to define focus styles! */input,select,.control,.ui-selectmenu-button,textarea,.pseudocheckbox,.pseudoradio,.controlWrapper,.textAreaWrapper,.lightBorder,.themed .ui-selectmenu-button,.ui-state-default { border-color: #333333;}.baseFontColor { color: #333333;}.baseColorPalette { background-color: #ffffff; color: #333333;}.accentBkg { background-color: #ebebeb; color: #333333;}.lightAccentBkg { background-color: #f3f3f3;}.veryLightAccentBkg { background-color: #f9f9f9;}.darkAccentBkg { background-color: #cccccc; color: #333333;}.ghostBorder { border-color: #8f8f8f;}.gateway.themed .accentBkg .borderInAccentBkg { border-color: #cccccc;}.linkColorOnBkg { background-color: #ffffff; 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