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Quality Engineer

Location : Charlotte, NC
Job Type : Direct
Reference Code : ML
Hours : Full Time
Required Years of Experience : 3+
Required Education : 4 year degree required
Travel : No
Relocation : No
Industry : Engineering

Job Description :

International medical manufacturing organization with a site in Charlotte, NC has an immediate need for a quality engineer to support total plant quality.




SUMMARY: Performs a variety of functions within the EDH QA Department, including a resource for the Focus Factory and support the Quality system. Promotes and maintains all company policies. Complies with the facility safety program and reports any unsafe conditions to management.




ESSENTIAL FUNCTIONS:



  • Supports and promotes all company policies. Supports and promotes the company Safety Policies.

  • Supports and maintains the quality system.

  • Serves as a Quality Assurance resource to assigned departmental functions.

  • Reports to management on quality concerns, trends and costs.

  • Participates and/or develops product and process validations.

  • Participates and/or develops new material qualifications.

  • Participate in New Product Development to assure quality considerations are adequately covered in the design, testing, and release of materials, components, and products.

  • Analyzes causes of defects and participates in recommendation of corrective actions.

  • Participates in the designing of methods for evaluating product quality; establishes test programs to evaluate materials, processes and products.

  • Prepares inspection instructions, systems and procedures.

  • Initiates actions to dispose of nonconforming product.

  • Analyzes causes of defects and participates in recommendation of corrective actions.

  • Participates in new supplier qualifications including supplier change requests and PPAP 


Required Qualifications :


  • 4-year Bachelor’s degree.

  • 2-4 year minimum Quality Assurance or other direct experience in a manufacturing environment – experience in a medical device, pharmaceutical or aerospace industry required.



  • Practical knowledge of FDA QSR 820, ISO13485 and GMP

  • Basic knowledge of statistical methods.

  • Other Skills: ASQ certification preferred

  • Previous experience using risk management tools such as PFMEA’s or other control plans

  • Extensive knowledge of Geometric Tolerance and Dimensions (GD&T)

  • Ability to work in a fast paced environment


  #LI-ML1

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