• Product Quality Engineer

    Position Location US-CA-Rancho Santa Margarita
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    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 Product Quality Engineer, you will be responsible for working within the framework of a team and performing the following activities:

     

    • Evaluate the performance of products returned by the customer
    • Perform device analysis in accordance with model-specific procedures and protocols
    • Perform root cause analysis to investigate alleged product deficiencies
    • Propose corrective/preventive actions as required
    • Compose detailed reports describing results from investigations
    • Complete evaluations in a timely and accurate manner

    Position Requirements

    This position requires the following skills and attributes:

     

    • Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or similar engineering discipline
    • Minimum of 1 year of experience in the medical device field or other regulated industry
    • Effective problem solving and troubleshooting skills
    •  Proficient computer skills, including knowledge of spreadsheets and word processing
    • Possess excellent oral and written communication skills
    •  Able to work independently, in a team environment and cross-functionally with other departments
    • Able to learn quickly and be self-motivated
    • Strong multitasking and prioritization skills
    • Ability to respond to the urgent needs of the team with a proven track record of meeting deadlines

    Preferred

    The following skills and attributes are preferred, but are not required:

     

    • Experience in conducting failure investigations, reliability testing and/or performing failure analysis leading to root cause and corrective/preventive actions
    • Working knowledge of FDA and ISO regulations
    • Working knowledge of manufacturing processes and equipment

    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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