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Quality Engineer II

Company: Ortho Development Corporation
Location: Draper
Posted on: January 8, 2022

Job Description:

As a Quality Engineer II you will apply Quality Engineering tools to ensure that Ortho Development products conform to specified requirements. This candidate will be responsible for the development, implementation, maintenance, and improvement of quality assurance processes. Throughout the implementation and maintenance process, this candidate should use data analysis to better understand quality reporting measures and improve processes.
Principal Responsibilities

  • Evaluation and disposition of nonconforming materials and processes (MRB/NCR).
  • Investigation of issues, planning, implementation and verifying effectiveness of Corrective Action (CAPA/SCAR)
  • Evaluation, investigation and resolution of Complaints (PIR/Feedback)
  • Create and review inspection plans (Control Plans).
  • Collects, trends and analyzes data from various sources to report on effectiveness of processes and controls (trending)
  • Contributes to Risk Management and Process Validation activities (FMEA, IQ/OQ/PQ, MSA)
  • Conducts internal audits of Quality Systems and Production processes and external audits of key suppliers (audit).
  • Evaluates proposed changes to ensure continued conformance to specified requirements.
  • Prepares and evaluates the results of First Article Inspection (FAI)Training and Experience
    Training and Qualifications
    • Bachelor's Degree in Science, Technology, Engineering or Math
    • 6-10 years experience in quality engineering and/or technician work
    • ASQ (or similar) Certification
    • Six Sigma certification
    • Minimum 2 years Engineering experience, Medical Device Industry and Quality Engineering experience will be given strong preference.
    • Candidates must be familiar with Quality Systems Regulations (e.g. 21 CFR) and ISO 13485.
    • Direct prior experience with most principal responsibilities.
      Additional InformationOrtho Development is a fast growing company nestled at the foot of the Wasatch Mountains. We help people do what they love by restoring mobility. Ortho has been designing and manufacturing orthopedic implants since 1994. Our main products include total hip arthroplasty, total knee arthroplasty, spine implants, and trauma plates and screws. We are an exciting place to work that provides autonomy for you to excel at your tasks. We offer competitive compensation and excellent benefits including:
      • Medical, Dental and Vision Insurance
      • Health Reimbursement Account
      • Flexible Spending Account
      • Company paid Life and AD&D Insurance
      • Long Term Disability Insurance
      • Tuition Assistance
      • 10 Paid Holidays
      • 15 days PTO to start
      • Quarterly Bonuses
      • Employee Discounts
      • 401K and 401K match
      • Employee Assistance Program
      • Wellness Coaching and Gym incentivesby Jobble

Keywords: Ortho Development Corporation, Draper , Quality Engineer II, Engineering , Draper, Utah

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