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Quality Engineer II

  • Anywhere

Company :
Applied Medical

Location :
Santa, Idaho

Expiry Date :
Sun, 06 Dec 2020 23:59:59 GMT

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Description :
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 validate test methods for design verification and manufacturing inspection testing by using 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 Performance Qualification (IQ, OQ, PQ) – Review engineering documents to ensure quality and compliance – Collaborate with design and manufacturing teams to assess device risk profile and 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 management standards – 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