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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.


  • 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


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