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    Quality Engineer III - Tucson, United States - Spectrum Plastics Group, A DuPont Business

    Spectrum Plastics Group, A DuPont Business
    Spectrum Plastics Group, A DuPont Business Tucson, United States

    2 weeks ago

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    Description

    POSITION SUMMARY:

    • This position is accountable for development, implementation, evaluation, and support of quality system activities for their assigned plant.
    • Manage specific aspects of the quality and product safety management systems including internal audit, calibration, nonconforming material control, inspection and test, and others as assigned by the Plant Quality Manager
    • Prepare appropriate quality-related reports as assigned by the Plant Quality Manager.
    • Represent the company in a professional manner when interacting with suppliers, customers, and internal stakeholders.

    ESSENTIAL DUTIES:

    • Manage internal audit program, including development of annual audit schedules, conducting audits, and assigning auditors, evaluating, and tracking audit reports and findings, initiating and following-up on corrective actions.
    • Ensures regulatory requirements like 21 CFR Part 820, MDSAP, ISO 13495, EU MDR, MDD are met.
    • Participate in new product qualifications and validations to ensure quality, product safety and regulatory requirements are addressed pre-production.
    • Participate in customer complaint and NCM investigations and other problem-solving efforts. Assist in measuring/collecting product and process data/information necessary to determine or validate root causes and permanent corrective actions.
    • Technical lead for inspections which includes defining methods and qualifying the method (TMV, Gage R&R)
    • Programming optical/vision-based measurement systems like MicroVu, Keyence etc.
    • Lead process automations like paperwork reduction, Quality 4.0 initiatives, Electronic QMS implementation.
    • Utilizing lean and six sigma tools to improve internal manufacturing and non-manufacturing processes.
    • Defines and implements quality system processes and procedures.
    • Understands all aspects of assigned production line(s) to help minimize scrap and complaints.
    • Implements corrective actions and uses CAPA system to consistently improve product quality.
    • Prepares written protocols and reports.
    • Performs a variety of complex tasks using experience and judgment.
    • Mentor junior level team members.
    • May lead and direct the work of others in various projects and assignments.
    • Upholds Spectrum Plastics vision and core values.
    • Performs other duties as required.

    QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities)

    Required:

    • Bachelor's degree or higher in Engineering (Mechanical/Industrial/Engineering Management/Biomedical/Electrical)
    • 7 + years of industry experience in a similar role
    • Has knowledge of commonly used concepts, practices, and procedures within the field, including regulatory affairs.
    • Ability to problem solve, identify errors and deficiencies and perform research independently
    • Ability to apply knowledge to their job function using pre-established guidelines and instructions
    • Accuracy, attention to detail, and thoroughness
    • Proficient in computer skills and ability to use MS office, Minitab etc.
    • Proficient communications skills
    • A wide degree of creativity and latitude
    • Ability to comprehend and comply with company safety and quality standards
    • Ability to follow oral and written instructions

    Preferred:

    • Previous experience in Quality Assurance
    • Rudimentary knowledge of statistics
    • Medical device experience
    • Certified Quality Engineer (CQE)
    • Lean Six Sigma Green Belt or Black Belt

    WORKING CONDITIONS:

    This position requires about 50% of time spent sitting and working on computer. The other 50% of time would be spent moving around on the Production floor where protective clothing is necessary.

    NOTE: This job description is not intended to be an exhaustive list of all possible duties, responsibilities and or qualifications. Other duties, responsibilities and/or qualifications may be assigned to this position.

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