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Quality Assurance Engineer (ISO 9001/13485)

Company: Jobot
Location: Huntington Beach
Posted on: February 14, 2021

Job Description:

Calling all Quality Assurance Engineers

This Jobot Job is hosted by Mordy Ornguze
Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume.
Salary $71,000 - $100,000 per year

A Bit About Us

We're a leading assistive technology provider for the visually impaired and owner of the brands AI Squared, Enhanced Vision, Freedom Scientific, Optelec, The Paciello Group and Interactive Accessibility. All our brands have a long history of developing and providing innovative solutions for blind and low vision individuals, helping them to reach their full potential.

We describe out Company culture as

  • Detail-oriented -- quality and precision-focused
  • Innovative -- innovative and risk-taking
  • Aggressive -- competitive and growth-oriented
  • Outcome-oriented -- results-focused with strong performance culture
  • Stable -- traditional, stable, strong processes
  • People-oriented -- supportive and fairness-focused
  • Team-oriented -- cooperative and collaborative

    Why join us?

    • 401(k)
    • 401(k) matching
    • Dental insurance
    • Flexible schedule
    • Flexible spending account
    • Health insurance
    • Health savings account
    • Life insurance
    • Paid time off
    • Referral program
    • Retirement plan
    • Vision insurance

      Job Details

      Quality Engineer
      The Quality Engineer will provide Quality Control and Manufacturing support to ensure all products meet our customer requirements. Develop process control and establish appropriate control system. Perform and document internal quality audits and make required recommendations. This role will report to the Director of Quality Assurance.

      About You...
      • Excellent decision making and analytical skills
      • Excellent written and oral communications
      • Detail oriented with ability to pay attention to minute details for a project or task
      • Self- motivated with the ability to be internally inspired to perform a task to the best of one's ability using his or her own drive or initiative
      • Motivated and quick learner able to work independently and as a team member

        • Develop and document work instructions for product inspection to ISO 9001/13485 requirement and Medical Device Regulations.
        • Ensure compliance to ANSI/ASQC Z1.4-1993 (sampling).
        • Lead and participate in Continuous Process Improvement and lean initiatives.
        • Review engineering changes (ECO) for QC and Implement requirements.
        • Perform Internal Audits of Processes and Procedures per schedule.
        • Organization and monitoring of all production tools and equipment for calibration or maintenance.
        • Leads investigation, containment and prevention of customer quality problems and manage completion of corrective actions requests to reduce Out of box defects and customer quality incident reports.
        • Provides Quality oversight and feedback to other departments as appropriate to preclude future recurrences of problems.
        • Validates and analyzes organizational customer quality metrics and performs periodic reviews to evaluate results and recommendation action plans to close gaps in the supply chain.
        • Other duties may be assigned.

          Required Skills/Qualifications
          • Excellent PC skills in Windows, Excel, Word and Power Point.
          • Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
          • Comprehensive knowledge of statistical tools, control plans, problem solving methods, i.e. 8D and the associated statistical tools used to analyze problems, evaluate and complete improvement projects.
          • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
          • Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
            • Required - 4 Year College Degree or 3 years related experience and/or training; or equivalent combination of education and experience. Preferred - ISO 9001/13485 training/ certificate of completion. 5S, Lean Manufacturing, Kaizen and SPC experience.
            • Previous Project Management experience preferred.

              Interested in hearing more? Easy Apply now by clicking the "Apply" button.

Keywords: Jobot, Huntington Beach , Quality Assurance Engineer (ISO 9001/13485), Engineering , Huntington Beach, California

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