Save JobEmail Job Back to Search Job Description Summary Similar JobsSignificant progression and growth opportunitiesCapital backed Medical Device Start-up with great benefitsAbout Our ClientOur Client is a Medical Device Start-up specializing in creating a custom display solution for hospital monitoring use. They are looking to bring on a Quality Engineer to their growing team. The company prides itself on being cutting edge and providing a solution thats not only going to revolutionize the medical device industry but also save lives.Job DescriptionPerform duties and responsibilities assigned by Director of QualityPerform product, process, and change control risk mitigation actions, utilizing: Control Plans, pFMEAs, Flow DiagramsRisk Assessment Audits, 5S Audits and ISO based Internal AuditsWork Instructions, Process Mapping and ChecklistsProvide support for gage calibration program to meet ISO 9001 & ISO 13485 requirementsCreate and implement new ISO 9001 and ISO 13485 procedures and work instructionsProvide quality engineering support to all departments.Performs statistical analysis and write technical reportsMPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.The Successful ApplicantBachelor's Degree from an accredited college or universityExperience working in an environment certified to ISO 13485:2016 and CGMP Good Manufacturing Practices and the FDAExperience with Lean / Six Sigma Problem Solving toolsAbility to work with mathematical concepts such as probability and statistical analysisGood understanding of SPC and Gage R&R including conducting studies and reporting resultsWhat's on OfferCompetitive base salary, dependent on experience, between $85,000 and $95,000Medical, dental and vision insurance through BCBS15 days of Vacation5 Sick Days + 2 Personal Days10 Paid Holidays3% 401k MatchTuition reimbursementContactMegan McdonaldQuote job refJN-032023-5983084Job summarySectorEngineering & ManufacturingSub SectorQuality, TechnicalIndustryIndustrial / ManufacturingLocationChicagoContract TypePermanentConsultant nameMegan McdonaldJob ReferenceJN-032023-5983084