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Title

Quality Inspector II 

About the Organization Founded in 2004, Structure Medical was built on the belief that life-changing technology is only as powerful as the people behind it. This fundamental philosophy of putting people first is reflected in every facet of our company culture and directly linked to our success and longevity as the premiere manufacturer of medical implants, instruments, and cutting tools for orthopedic surgeons worldwide. The company employs nearly 350 people across three locations; warm and sunny Naples, Florida, scenic and picturesque Mooresville, North Carolina, and in the technological hub of Madison, Alabama. Our clean, state-of-the-art facilities utilize the most advanced machine tools available to produce products that meet the highest quality standards.

Benefits


Our company offers the following benefits:


  • Competitive Salary

  • On-the-Job Training

  • Health, Dental & Vision Insurance

  • 401(k) Retirement Plan

  • Flexible Spending Account

  • Paid Holidays & Paid Time Off

  • Employee Assistance Program

  • And more!
  •  
    Description

    JOB SUMMARY:

    Performs technical quality inspection work for Structure Medical, LLC. Performs inspections on customer products to ensure that they conform to specifications. Performs process validation measurements to include gage R&R and capability studies. Work is performed under general supervision with limited latitude. Position exercises some judgment in accordance with well-defined policies, procedures, and techniques.

    EXAMPLES OF ESSENTIAL FUNCTIONS:

    The list of essential functions, as outlined herein, is intended to be representative of the tasks performed within this classification. It is not necessarily descriptive of any one position in the class. The omission of an essential function does not preclude management from assigning duties not listed herein if such functions are a logical assignment to the position.

    • Conducts and documents first article, in-process, and finished product inspections to determine if products are in compliance with order specifications; notifies the Production department accordingly
    • Tags and isolates non-conforming parts; notifies the Quality Control Manager and operator(s)
    • Writes non-conformance reports ensuring compliance with applicable rules and regulations
    • Performs process validation measurements to include gage R&R and capability studies; reviews raw material listed on travelers
    • Records test data applying statistical quality control procedures
    • Evaluates data to identify deviations from specifications
    • Recommends modifications to existing quality and production specifications to achieve optimal quality within the limits of equipment capability
    • Understands and works toward Quality objectives and cost containment; continually optimizes the inspection process by identifying Quality bottlenecks that hinder production
    • Writes work instructions as required
    • Assists with the Material Review Board (MRB), QA Final Release, and processing Engineering Change Orders (ECO’s)
     
    Location Structure Medical LLC - Naples, FL  
    Full-Time/Part-Time Full-Time  
    Shift Second  
    Position Requirements

    MINIMUM QUALIFICATIONS:

    High school diploma or GED; technical certificate preferred; supplemented by two or more years’ experience in quality inspections in a mid to heavy manufacturing environment; or an equivalent combination of education, certification, training, and/or experience.

    KNOWLEDGE, SKILLS, AND ABILITIES:

    • Knowledge and understanding of ISO 13485 and FDA 21CFR820 as it pertains to the job
    • General knowledge of CMM operation, measuring tools, including but not be limited to, calipers, micrometers, depth gages, indicators, and plug and tread Go/No Go gages; may be trained on the job
    • Skilled in the use computer software including but not limited to Microsoft Outlook, Word, and Excel and Visual Enterprise Resource Planning (ERP) software
    • Skilled in basic math including but not limited to adding, subtracting, multiplication, division, geometric construction, practical algebra and metrics for the purpose of calculating material specifications
    • Skilled in setting priorities that move projects through efficiently to achieve customer and quality objectives
    • Skilled in working independently and following through with assignments with minimal supervision
    • Ability to read blueprints preferred
    • Ability to establish and maintain effective and cooperative working relationships with those contacted in the course of work
    • Ability to learn and adapt to changing technology
    • Ability to clearly communicate and understand information in English, both orally and in writing
    • MUST BE WILLING TO WORK ANY SHIFT
     
    EOE Statement Structure Medical LLC is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, pregnancy, age, handicap, marital status and genetic information, or any other characteristic protected by law.

     
    Relocation Assistance Relocation assistance may be available to out-of-state candidates.  
    Salary Range Salary will commensurate with experience.  

    This position is currently not accepting applications.

    To search for an open position, please go to http://StructureMedical.appone.com



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