Save JobEmail Job Back to Search Job Description Summary Similar JobsGrowing Medical Device Startup with commercially accessible products in the USWork with the Director of Quality Assurance in a dynamic, high-visibility roleAbout Our ClientOur client spent many hours shadowing physicians to learn about the struggles of vascular access during procedures. After trial and error, our client developed and perfected their patent approved, unique-to-market catheter offering the least intrusive option for vascular visual access. With two products on the market and more on the way, our client is growing and looking to make additions to the team to match this financial growth.Job DescriptionThe Senior Quality Engineer will:Provide Quality Engineering support for New Product Development, Manufacturing, and other Supply Chain functions throughout all phases of Design ControlsThis is a collaborative position working closely with R&D, Manufacturing, Sales & Marketing, and others to ensure a constant state of control and compliance for QMS, and FDA QSR requirementsServe as Quality Engineer on New Product Development teams, leading Risk Management activities, collaborating on V&V and Design Transfer activitiesIdentify and implement effective process control systems to support product manufacturing, and new product development initiativesManage and administer to support the Nonconforming Product, CAPA, and Complaint Handling processesLead or participate in product / process improvement efforts utilizing methodical problem-solving approachesMPI 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 ApplicantThe Senior Quality Engineer should have:Bachelors of Science5+ years hands on medical device manufacturing experienceWorking knowledge of 21 CFR 820 and ISO 13485:2016 is a mustWorking knowledge of data analysis methods, including basic statistics, preferably using Minitab or other similar data analysis softwareCritical reasoning and excellent data presentation skillsSelf-initiator with strong organization skillsWhat's on OfferOur client can offer in return:Competitive base salary and benefitsBonus StructureHybrid Work ModelWork closely with the Director of Quality AssurancePlease reach out to Cameron Cyker with questions, and apply today!ContactCameron CykerQuote job refJN-062022-5633517Job summarySectorEngineering & ManufacturingSub SectorSix Sigma, Lean, Process improvementIndustryIndustrial / ManufacturingLocationWoburnContract TypePermanentConsultant nameCameron CykerJob ReferenceJN-062022-5633517
