Quality Engineer

Nov 16, 2023

Job ID:136551


Job Position: Quality Engineer

Location: Waynesville, NC 28786

Pay Rate: $90000.00-105000.00





The Quality Engineer assists in planning, development, implementation, communication and maintenance of the quality management systems, policies, documentation, data and customer-specific requirements for all Sulfate Manufacturing facilities





  • Monitor, assess and improve inspection processes for raw materials and finished goods along with corresponding work instructions and documentation

  • Responsible for daily, weekly and monthly inspection reports

  • Key User of Master Control QMS Software

  • Monitor, analyze and trend quality performance

  • Ensures that workflows, processes, and products comply with all regulatory and safety requirements

  • Corrective/Preventive Action owner to drive actions, solutions and improvements

  • Primary driver of the Change Control process including all necessary inputs and outputs

  • Support Equipment Validation activities per regulatory compliance

  • Ability to perform risk assessments for new equipment, processes, or changes to either

  • Work in conjunction with the Quality Team to support and perform internal audit-readiness activities as well as support the Team for Regulatory and Customer audits

  • Ability to communicate effectively with all levels of staff and management, both internal and external

  • Excellent organization skills with the ability to perform multiple tasks and obtain results working within strict time frames

  • Strong attention to detail

  • Solid knowledge of good manufacturing practices within an FDA-regulated facility

  • All other duties, responsibilities, and activities that may be assigned. 




  • Bachelor’s degree in engineering or equivalent discipline or work experience

  • Minimum of 2 to 5 years’ experience in a manufacturing environment preferred

  • Experience with FDA: CFR 210/211 preferred

  • ISO 9001-2018 experience preferred

  • Root cause analysis, analytical and problem-solving experience preferred

  • ASQ Certification preferred

  • Intermediate to advanced math and statistical skills

  • Ability to communicate technical terms in common sense manner to all levels of organization and externally

  • Strong organizational and information management skills required

  • Proficient in Microsoft Office products

  • Solid base of knowledge with respect to Quality Management Software

  • Ability to work in cross-functional teams

  • Excellent project management skills

  • Capacity to work independently from general supervision (must be self-motivated once given guidance/direction)

  • Good oral and written communication