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Quality Engineer II

Company: Jobleads
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 II Position Location US-CA-Rancho Santa Margarita _________________________________________________________________________________ Applied 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 Description As 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. Responsibilities Conduct experiments to prove hypotheses Create and validatetest methods for design verification and manufacturing inspection testing byusing measurement system analysis, gauge R&R and other relevant techniques Implement statistical techniques to determine sample sizes and levels of confidence Implement statistical process controls to monitor validated processes Design engineering test protocols and use a data-driven approach to collect, analyze and summarize data into engineering reports Perform root cause investigations for design and manufacturing Document Non-Conformance Investigations (NCIR) Document and implement Corrective and Preventative Actions (CAPA) Generate protocols and reports for Installation, Operational and PerformanceQualification (IQ, OQ, PQ) Review engineering documents to ensure quality and compliance Collaborate with design and manufacturing teams to assess device risk profileand failure modes in design (dFMEA)and manufacturing (pFMEA) Position Requirements 1-2 years of relevant work experience Bachelor's degree in an Engineering or STEM field or related education and experience Experience in process verification and validation procedures Exposure to ISO 9001 and ISO 13485 Exposure to CFR 21 Exposure to FMEA Understanding of manufacturing, quality and risk managementstandards Effective oral and written communication skills Excellent technical writing Ability to work effectively in cross-functional teams Ability to read, analyze and interpret complex documents Preferred Experience in the medical device industry Working knowledge of statistics as it applies to verification testing and process control, and previous use of statistical analysis software, such as Minitab Experience with project management tools (i.e. Microsoft Project) Experience with software such as NetWeaver/Product Lifecycle Management Experience with leading a team or project Benefits Training and mentorship with ongoing learning and development courses On-campus wellness activities Comprehensive medical and dental and vision coverage Education reimbursement program 401(k) program with discretionary employer match Generous vacation accrual and paid holiday schedule Options Apply 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 Employer Application FAQs

Keywords: Jobleads, Rancho Santa Margarita , Quality Engineer II, Other , Rancho Santa Margarita, California

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