QUALITY MANUFACTURING ENGINEER Position
Full Time *Not a Contract Position
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Education/Experience:
Overview:
β’ Contribute to the maintenance of the overall quality system, ensuring compliance with applicable ISO standards, FDA QSRβs, and any other applicable laws and regulations.
β’ Revise Quality System documentation as necessary to comply with all applicable regulations and statutory requirements.
β’ Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards.
β’ Select products for tests at specified stages in production process, and test products for variety of qualities such as dimensions, performance, and mechanical, or chemical characteristics.
β’ Record test data, applying statistical quality control procedures.
β’ Evaluate data and write reports to validate or indicate deviations from existing standards.
β’ Set up and perform destructive and nondestructive tests on materials, parts, or products, to measure performance life, or material characteristics.
β’ Prepare graphs or charts of data or enter data into computer for analysis.
β’ Operate personal computer using word processing, database, statistical, and spreadsheet software.
β’ Recommend modifications of existing quality or production standards to achieve optimum quality within limits of equipment capability.
β’ Ensure the integrity of all traceable information from incoming materials through outgoing finished products and components.
β’ Perform validation and verification testing according to written procedures or oral instructions.
β’ Maintain the calibration system ensuring the overall compliance to documented standards.
β’ Perform First Article Inspection and reporting on new or revised products or components ensuring compliance to specifications.
β’ Investigate product complaints by analyzing, measuring, surmising, and report writing.
β’ Develop & maintain Databases as required.
β’ Effectively deploy and maintain the Internal Audit program.
β’ Maintain the corrective and preventive action system. Conduct follow-up audits on corrective and preventive actions to ensure implementation and closure.
β’ Trend data related to defects, productivity, environmental conditions, and other applicable information to assist in optimizing manufacturing operations.
β’ Apply general rules to specific problems to produce logical answers; the ability to determine if the answer makes sense.
β’ Other duties directly related to the quality function may be assigned as necessary.
Qualifications
β’Β Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.β’ Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
β’ Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
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