• Specialist III/Engineer III

    Position Location US-CA-Rancho Santa Margarita
  • _________________________________________________________________________________

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

    • Drive projects to ensure compliance with domestic and international regulations and standards
    • Manage systems/processes to ensure effective reporting, trending and communication
    • Guide team members in the compilation, creation and completion of quality systems and/or regulatory documents
    • Identify and implement systems to improve the overall efficiency of processes within QS/RA
    • Participate in internal and external audits
    • Review, monitor, and approve programs/documentation, as assigned, to ensure compliance with relevant standards regulations and guidance documents
    • Interpret 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 teams to provide guidance on quality systems and/or regulatory systems compliance
    • Work closely with Director and/or VP of QS/RA
    • Meet or exceed customer expectations and commit to continued quality improvements

    Position Requirements

    This position requires the following skills and attributes:

    • Minimum of a bachelor’s degree in either Engineering, Physical Sciences or Biological Sciences or other technical discipline or equivalent
    • Demonstrated ability to successfully lead and strengthen teams and projects
    • Training in Quality Systems including QSR/GMPs and relevant ISO Standards
    • Read, write, speak and comprehend English
    • Minimum of 3 years of experience with a combination of Engineering, QS/RA and/or other relevant subjects in the medical device industry or equivalent
    • 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

    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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