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Quality Engineer

  • Specialty:

    Engineering
  • Title:

    Quality Engineer
    • City:

      Peachtree City
    • State:

      GA
    • Zip Code:

  • Start date:

    11-10-2020
  • Status:

    Closed
  • Assignment Type:

    Direct Hire
  • Job Id:

    55438

Description

Quality Engineer
We're currently working with a leading Medical Device manufacturing company in the Fayetteville Area looking for a skilled Quality Engineer to join their team. 

Responsibilities:

  • Provide Validation input (DOE, FAT, SAT) to cross-functional teams involving R&D, Marketing, Regulatory, developing medical devices.
  • Support line transfers, qualification and verification activities at site
  • Support supplier selection activities, address quality issues as they arise
  • Develop statistically relevant test methods, protocols and documentation to support manufacturing of medical devices.
  • Develop validated plans for joining operations like ultrasonic welding
  • Conduct technical reviews; ensure documentation is available to meet Quality Systems Requirements. (BOMs, Routers, FMEAs, etc.). 
  • Actively participates in concept review and development on new injection-molded products.
  • Support various teams and work closely with Design Engineering and Project Management to smoothly transition new products to production. Provide frequent and appropriate communications with all internal customers
  • Stay current on core competencies and best practices in manufacturing to ensure incorporation into new qualifications / validations.
  • Identify root cause and implements corrective and preventive measures to improve or ensure product quality across product lines.
  • Ensure product documentation and manufacturing processes meet all Quality system requirements.
  • Designs, installs, and continually evaluate quality assurance and/or control methods and Systems.
  • Conduct statistical analysis in the form of capability studies to evaluate processes.
  • Develop standards, procedures, and work instructions.
  • Apply in-depth knowledge of statistical techniques, with ability to identify, analyze and define possible solutions for continuous product and process improvement
  • Perform training in internal auditing, mechanical inspection and statistical techniques
  • Develop sampling plans and statistical methods to be utilized by manufacturing and inspection to include determination of control points and charting methods.
  • Interface with engineering and CMM programmers to design fixtures and processes to ensure the effectiveness of measurement systems.
  • Conduct internal and external audits and supplier surveys to verify capability and/or compliance.
  • Coordinate and participate in material review activities to determine nonconforming product dispositions and corrective actions.


Requirements:  

  • 4 year Engineering Degree and 5+ years of experience in the areas of quality management in the medical device field 
  • Ability to apply engineering principles to an idea or set of user requirements and then convert this into design requirements, considering manufacturability, cost of goods, and the regulatory requirements for a device or combination product.
  • Ability to develop injection molding and Assembly Validation Master plans.
  • Expertise in plastics testing – particularly ASTM and ISO mechanical tests.
  • Ability to make data-based and risk-based decisions to drive projects efficiently.
  • Good understanding of Design for Manufacturability principals, GAMP5, UL and EU electrical standards.
  • Expertise of FDA regulations and validation of automation equipment, i.e. SAT, FAT, IQ, OQ, PQ.

More Info

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