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    Quality Engineer III - Los Angeles, United States - Medix

    Medix
    Medix Los Angeles, United States

    3 weeks ago

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    Description

    Position Scope/Summary :

    The Quality Engineer III is primarily responsible for identifying problems, collecting data, analyzing trends, reporting findings, and initiating corrective and/or preventive actions related to in-process, product, and equipment quality issues.

    This role encompasses overseeing the quality aspects of qualifying and validating molds, products, processes, and equipment.


    Position Requirements :
    Identify problems, collect and analyze data, report findings, and initiate corrective and/or preventive actions.
    Manage Non-Conformance Reports (NCRs) from opening to closure.
    Handle complaints from opening to closure.
    Drive Continuous Quality Improvement across systems, documents, software, and technical tools, updating procedures as necessary.
    Take ownership of product lines and engage in customer-facing roles.
    Report internal and external quality problems and trends.
    Execute validations and coordinate activities between Engineering, Manufacturing, and Quality, including qualification and validation processes.
    Monitor and improve Statistical Process Control (SPC) systems, sampling plans, and statistical methods.
    Conduct Cost of Quality reporting and analysis as needed.
    Provide training to personnel to enhance technical skills, job knowledge, and performance.
    Develop control plans and Process Failure Mode and Effects Analysis (PFMEAs).
    Plan, prepare, and conduct Internal Audits as assigned.
    Lead Material Review Board (MRB) and Corrective and Preventive Action (CAPA) meetings.
    Collaborate with other departments as a member of problem-solving teams.
    Represent the company with customers, vendors, and external auditors.
    Prepare for and participate in audits such as Customer, Supplier, and FDA inspections.
    Contribute to inputs for management review meetings.


    Qualifications :
    Bachelor's Degree in a technical field or equivalent work experience.
    Required – Minimum five (5) years of experience in a similar field.
    Certification as an Internal Auditor. Proficient in problem-solving methodologies, math, statistics, and reading comprehension.
    Strong understanding of Quality Management Systems (QMS). Excellent oral and written communication skills.
    Demonstrated knowledge of Quality System Regulations (e.g., Complaint, NCR, root cause analysis).
    Proficient in quality statistics (e.g., AQL, sampling).
    Preferred – At least two (2) years of experience in a supervisory or management role.
    Demonstrated leadership in teams and projects. Strong organizational skills. Previous experience in a plastic injection molding environment.
    Green Belt in Six Sigma preferred.

    Specialized Knowledge:
    Experience in medical devices or other FDA-regulated industries.
    Comprehensive understanding of ISO 9001, ISO 13485, JPAL MHLW Ordinance 169, and/or FDA QSR regulatory requirements.
    Proficiency in MS Word, Excel, and Access.
    Desired experience in Measurement System Analysis (MSA), SPC, Mini-tab, Infinity, sterilization, and clean room environments.

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