• Quality Engineer I

    Position Location US-CA-Rancho Santa Margarita
  • _________________________________________________________________________________

    Applied-Medical-Logo-w-Tag_H_Teal_cropped

    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 I, you will learn and develop skills to support medical device quality through design controls, process validations and documentation as part of a cross-functional team.

     

    Responsibilities

    Receive guidance to complete the following:

    • 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)
    • Collaborate with design and manufacturing teams to assess device risk profile and failure modes in design (dFMEA) and manufacturing (pFMEA)

    Position Requirements

    • Bachelor’s degree in an Engineering or STEM field or related education and experience
    • Effective oral and written communication skills
    • Excellent technical writing skills
    • Ability to work effectively in cross-functional teams
    • Ability to read, analyze and interpret complex documents
    • Working knowledge of MS Office, including Word, Excel and Outlook

    Preferred

    • Experience in the medical device industry (i.e. internships or co-ops)
    • Engineering capstone projects related to medical or surgical devices
    • Experience in process verification and validation procedures
    • Experience with project management tools (i.e. Microsoft Project)
    • Working knowledge of statistics as it applies to verification testing and process control, and previous use of statistical analysis software, such as Minitab
    • Understanding of manufacturing, quality and risk management standards

    Benefits

    • Training and mentorship with ongoing learning and development courses
    • On-campus wellness activities
    • Comprehensive medical and dental coverage
    • Education reimbursement program
    • 401(k) program with employer match
    • Generous vacation accrual and paid holiday schedule

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