• Quality Engineer

    Job Location US-OH-Dunbridge
  • Overview

    The purpose of this position is to support ISO 9001 maintenance efforts; provide statistical expertise geared toward quality improvements; provide expertise and guidance in regards to statistical thinking, sampling plans, FMEA and control plan implementation, process capability studies and measurement system analysis; support problem solving and corrective action efforts; and support internal auditing activities.


    • Knowledge of ISO 9001 standards and good manufacturing practices in order to maintain a quality management system in a manufacturing setting.
    • Identify, analyze and implement quality improvement parameters, by identifying statistical methods relevant to manufacturing processes, which will improve capability and performance.
    • Resolve quality issues of capability, tolerancing, and materials-related issues.
    • Determine when process stability and capability studies should be performed on existing processes.  Review and analyze results.  Recommend changes to processes based upon findings and perform follow up to verify effectiveness.
    • Establish statistical confidence by identifying sample size and acceptable error; determining levels of confidence.
    • Develop sampling plans by applying attribute, variable, or other sampling methods.
    • Maintain statistical process controls by applying demerit/unit, zone charting, X-bar/R charts.
    • Develop and maintain Control Plans and Failure Mode Effects Analysis (FMEA).
    • Facilitate and promote use of appropriate problem solving techniques for effective root cause analysis and successful corrective action to eliminate product nonconformities and customer complaints.
    • Analyze data by completing hypothesis, normal distribution, and process capability analysis tests.
    • Resolve quality issues by identifying problems, examining solution options, implementing action plans, and providing resources
    • Assist in the implementation of quality management system software
    • Create and maintain quality system documentation such as quality manual, standard operating procedures, work instructions, forms, master lists, etc.
    • Participate in product quality planning activities to determine appropriate use of existing and new measurement systems during new tool or process design and startup. Determine and apply appropriate Measurement System Analysis tools.
    • Carry out internal product, process or system audits. Carry out external supplier audits.
    • Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies


    • Bachelor’s Degree in Business or Engineering required
    • At least 3 years of experience required
    • Prior experience working with a formal quality management system (ISO 9001 or ISO 13485) and QMS software
    • Sound mathematical and technical skills
    • Good investigative and problem-solving skills, with excellent attention to detail
    • Ability to think logically and analytically
    • Good interpersonal skills and organizational skills
    • Knowledge of manufacturing methods and procedures
    • Excellent verbal and written communication skills
    • Knowledge of statistical packages and Microsoft Office systems
    • American Society for Quality – Certified Quality Engineer (ASQ-CQE) and/or Six Sigma certification preferred


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