• Specialist I,II/Engineer I,II

    Position Location US-CA-Rancho Santa Margarita
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    Applied-Medical-Logo-w-Tag_H_Teal_cropped

     

    Applied Medical is a new generation medical device company with a proven business model and commitment to innovation that has fueled our rapid business growth and expansion. Applied Medical has been developing and manufacturing advanced surgical technologies for nearly 30 years, and has earned a strong reputation in healthcare.  Our dedication to delivering the highest quality products and unique business positioning, provides our team members with the unique ability to contribute in a larger capacity than is possible in typical positions.

    Position Description

    As a Specialist I/II or Engineer I/II on the Regulatory Affairs(RA)/Quality Systems(QS) Team, you will be responsible for working within the framework of a team and performing the following activities:

    • Monitor and ensure conformance through the understanding of standards and regulations
    • Manage projects to maintain and improve the quality system by establishing or updating procedures
    • Participate in internal and external audits
    • Identify and implement systems within RA/QS
    • Review, monitor and approve programs and documentation
    • Interprets existing and emerging regulations, standards and guidance documents
    • Provide guidance, and evaluate and present reports in quality data trending and analysis
    • Act as a liaison to internal and external customers
    • Mentor new team members
    • Meet or exceed customer expectations and commit to continued quality improvements
    • Follow Applied Medical’s Quality Systems
    • Comply with safety rules and company policies

    Position Requirements

    This position requires the following skills and attributes:

    • Read, write, speak and comprehend English
    • Minimum of 1 year of experience in the medical device industry
    • Able to work independently as well as in a team setting
    • Analytical, meticulous and detail-oriented
    • Effective oral and written communication/presentation skills; strong technical writing skills
    • Ability to multi-task, organize and prioritize
    • Effective leadership/mentoring and guidance skills

    Preferred

    The following skills and attributes are preferred:

    • Training in Quality Systems including QSR/GMP; relevant ISO standards
    • Training in Quality principals
    • Bachelor’s degree in either Engineering, Physical Sciences or Biological Sciences; other technical discipline or equivalent

    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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