Quality Engineer II

Company: Applied Medical
Location: Rancho Santa Margarita
Posted on: May 3, 2021

Job Description:

Quality Engineer II in Rancho Santa Margarita, California | Careers at Applied Medical Skip to Main Content Please Enable Cookies to Continue Please enable cookies in your browser to experience all the personalized features of this site, including the ability to apply for a position. WELCOME PAGE Returning Candidate? Log back in!Quality Engineer IIPosition Location US-CA-Rancho Santa MargaritaApplied Medical is a rapidly growing, global organization that develops, manufactures and distributes medical devices to more than 75 countries. Our driving purpose is to satisfy the three fundamental healthcare needs: enhanced clinical outcomes, outstanding value and unrestricted choice. For 30 years, Applied Medical has been at the forefront of innovation and technology. As a result of our highly vertically integrated business model, we control all of our processes in-house, from R&D concept to clinical implementation. Applied Medical engineers take a hands-on approach, utilizing in-house cutting-edge technologies, such as automation and robotics, advanced metal processing, injection molding, and rapid prototyping. We invest heavily in R&D, advanced technologies and most importantly - the growth of our team members.Applied Medical is proud to have a culture firmly grounded in teamwork, collaboration and regulatory compliance, while providing opportunities for growth and choice in individual career paths.Position DescriptionAs a Quality Engineer II, you will use your skills to support medical device quality through design controls, process validations and documentation as part of a cross-functional team.ResponsibilitiesConduct experiments to prove hypothesesCreate and validate test methods for design verification and manufacturing inspection testing by using measurement system analysis, gauge R&R and other relevant techniquesImplement statistical techniques to determine sample sizes and levels of confidenceImplement statistical process controls to monitor validated processesDesign engineering test protocols and use a data-driven approach to collect, analyze and summarize data into engineering reportsPerform root cause investigations for design and manufacturingDocument Non-Conformance Investigations (NCIR)Document and implement Corrective and Preventative Actions (CAPA)Generate protocols and reports for Installation, Operational and Performance Qualification (IQ, OQ, PQ)Review engineering documents to ensure quality and complianceCollaborate with design and manufacturing teams to assess device risk profile and failure modes in design (dFMEA) and manufacturing (pFMEA)Position Requirements1-2 years of relevant work experienceBachelor's degree in an Engineering or STEM field or related education and experienceExperience in process verification and validation proceduresExposure to ISO 9001 and ISO 13485Exposure to CFR 21Exposure to FMEAUnderstanding of manufacturing, quality and risk management standardsEffective oral and written communication skillsExcellent technical writingAbility to work effectively in cross-functional teamsAbility to read, analyze and interpret complex documentsPreferredExperience in the medical device industryWorking knowledge of statistics as it applies to verification testing and process control, and previous use of statistical analysis software, such as MinitabExperience with project management tools (i.e. Microsoft Project)Experience with software such as NetWeaver/Product Lifecycle ManagementExperience with leading a team or projectBenefitsTraining and mentorship with ongoing learning and development coursesOn-campus wellness activitiesComprehensive medical and dental and vision coverageEducation reimbursement program401(k) program with discretionary employer matchGenerous vacation accrual and paid holiday scheduleOptionsApply for this position online Apply Share Email this position to a friend Refer Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed Loading...Need help finding the right position?We can recommend positions specifically for you!Click here to get started.Applied Medical is an Equal Opportunity EmployerApplication FAQsSDL2017

Keywords: Applied Medical, Rancho Santa Margarita , Quality Engineer II, Other , Rancho Santa Margarita, California