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Job Details

Quality Engineer II

Location
Fort Collins, CO, United States

Posted on
May 21, 2020

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Profile

u003cpu003eu003cstrongu003ePurpose and Scopeu003c/strongu003eu003c/pu003enu003cpu003eThe Quality Engineer II supports Quality Assurance by analyzing data and identifying trends in product/process data that can affect product quality. This is accomplished by authoring Annual Product Reviews (APRs) and supporting the Continued Process Verification (CPV) program.u0026nbsp;u003c/pu003enu003cpu003eu003cstrongu003eu0026nbsp;u003c/strongu003eu003cstrongu003eEssential Duties u0026amp; Responsibilitiesu003c/strongu003eu003c/pu003enu003culu003enu003cliu003eComplete Annual Product Reviews (APRs) in a timely manner in compliance with regulatory requirements.u003c/liu003enu003cliu003eTeach, mentor, and assist system owners with preparing, trending, and analyzing their data for Annual Product Reviews (APRs).u003c/liu003enu003cliu003eComplete Continued Process Verification (CPV) reports in a timely manner in compliance with regulatory requirements.u003c/liu003enu003cliu003eCompile information and data for Tolmaru0026rsquo;s commercial products.u003c/liu003enu003cliu003ePerform statistical analysis of data, identify trends in the product/process data that can affect product quality, and summarize the results, data analysis, and conclusions in technical reports.u003c/liu003enu003cliu003eUse statistical analysis and six sigma tools to assist with investigations related to the Continued Process Verification (CPV) program.u003c/liu003enu003cliu003eParticipate in Continuous Improvement (CI) projects related to the Continued Process Verification (CPV) program.u003c/liu003enu003c/ulu003enu003culu003enu003cliu003ePerform various other duties as assigned.u003c/liu003enu003c/ulu003enu003cpu003eu0026nbsp;u003c/pu003enu003cpu003eu003cstrongu003eKnowledge, Skills u0026amp; Abilitiesu003c/strongu003eu0026nbsp;u003c/pu003enu003culu003enu003cliu003eProficient knowledge with statistical software packages and MS Office.u003c/liu003enu003cliu003eAbility to read, understand, and author complex technical documents.u003c/liu003enu003cliu003eAbility to apply logical thinking in order to break complex problems into their component parts.u003c/liu003enu003cliu003eExcellent communication skills demonstrated through interactions internally and externally.u003c/liu003enu003cliu003eAbility to work independently and in conjunction with a team on multiple projects simultaneously in order to meet time lines.u003c/liu003enu003cliu003eEffective organization and project management skills.u003c/liu003enu003cliu003eStrong attention to detail, thorough, and efficient.u003c/liu003enu003c/ulu003enu003cpu003eu0026nbsp;u003c/pu003enu003cpu003eu003cstrongu003eCore Valuesu003c/strongu003eu003c/pu003enu003culu003enu003cliu003eThe Quality Engineer II is expected to operate within the framework of Tolmaru0026rsquo;s Core Values:u003c/liu003enu003culu003enu003cliu003eConsistently operate with the highest standards of ethics and compliance.u003c/liu003enu003cliu003eTake ownership of your actions, success and setbacks.u003c/liu003enu003cliu003eRespect each other and understand that honest collaboration is at the heart of our company success.u003c/liu003enu003cliu003eGo the extra mile to make things happen.u003c/liu003enu003cliu003eBe committed to all we do and the patients we serve.u003c/liu003enu003cliu003eEmbrace change with enthusiasm.u003c/liu003enu003cliu003eStrive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.u003c/liu003enu003c/ulu003enu003c/ulu003enu003cpu003eu003cstrongu003eu0026nbsp;u003c/strongu003eu003c/pu003enu003cpu003eu003cstrongu003eEducationu003c/strongu003e u003cstrongu003eu0026amp; Experienceu003c/strongu003eu003c/pu003enu003culu003enu003cliu003eBacheloru0026rsquo;s degree in Chemistry, Engineering, Biology, or other related field required.u0026nbsp;u003c/liu003enu003cliu003eFive or more years in Quality Engineering or related experience in the pharmaceutical, medical device, or biotech industry required.u0026nbsp;u003c/liu003enu003cliu003eCSSGB, CSSBB, or CQE preferred.u003c/liu003enu003c/ulu003enu003cpu003eu003cstrongu003eu0026nbsp;u003c/strongu003eu003cstrongu003eWorking Conditionsu003c/strongu003eu003c/pu003enu003culu003enu003cliu003eWorking conditions are normal for an office environment. Work may require occasional weekend and/or evening work.u003c/liu003enu003cliu003eOccasional work inside manufacturing clean rooms where gowning is required.u003c/liu003enu003c/ulu003e,EqualOpportunityEmployerDescription:Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities,PayTransparencyPolicyStatement:The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c),MatchScore:1.0,HasApplied:false,ApplicationJobBoardName:null,ApplicationJobBoardId:null,DateApplied:null,Salaried:true,CompensationAmount:null,PublishingStatus:1,Links:[],BehaviorCriteria:[],MotivationCriteria:[],EducationCriteria:[{Required:false,Related:true,DegreeId:db8ce9cd-2bd6-4487-a4a0-47203252a091,DegreeName:Bachelors,MajorId:d4d4243f-5944-42db-983c-955fae18f5d2,MajorName:Biology},{Required:false,Related:true,DegreeId:db8ce9cd-2bd6-4487-a4a0-47203252a091,DegreeName:Bachelors,MajorId:6d847f12-3a3d-4f5a-be2c-86bd2e504162,MajorName:Engineering},{Required:false,Related:true,DegreeId:db8ce9cd-2bd6-4487-a4a0-47203252a091,DegreeName:Bachelors,MajorId:79779e92-9bb1-4e54-806e-d5df6385d07b,MajorName:Chemistry}],LicenseAndCertificationCriteria:[],SkillCriteria:[],WorkExperienceCriteria:[],JobBoardMemberships:[{JobBoardId:d1569a66-00f5-4887-b2a9-048c2d9169a7,PublishedInternal:true,PublishedExternal:true,ExternalPostedDate:2020-05-21T16:58:27.999Z,InternalPostedDate:2020-05-21T16:58:27.999Z}],AssessmentUri:null,AssessmentStatus:null,OpportunityIsClosed:false,TravelRequired:null,TravelDescription:null,SupervisorName:null,Assessments:[],ApplicationId:null});

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