Quality Assurance Specialist

7 hours ago

Covington, Georgia, United States MILLENNIUMSOFT Full time
Job Title: Quality Engineer

Job Summary:


We are seeking a highly skilled Quality Engineer to join our team at MillenniumSoft. The successful candidate will be responsible for reviewing and assessing quality notifications, complaints, deviations, and waivers for assigned product lines. They will oversee operations, ensure documentation and procedures are followed, and maintain quality systems in accordance with FDA/GMP guidelines.


Key Responsibilities:


  • Review and assess quality notifications, complaints, deviations, and waivers for assigned product lines.
  • Oversee operations to ensure documentation and procedures are followed.
  • Maintain quality systems in accordance with FDA/GMP guidelines.
  • Conduct complaint investigations and assist in the investigation of manufacturing issues.
  • Provide data and input on technical issues and projects.
  • Develop solutions to problems of moderate scope and complexity.
  • Use policies and procedures for guidance.
  • Capable of using Microsoft programs and ability to learn other systems.
  • Working knowledge of statistical methods and statistical application software.
  • Effective verbal and written communication skills.
  • Ability to work in teams and independently with minimal supervision.

Requirements:


  • BS or BA in a related field with 4 years of experience, or MS with 3 years of experience required.
  • Project management experience preferred.
  • Typical degree in Mechanical or Electrical or Industrial Engineering, Biological Sciences, Chemistry, and/or Computer Science or other related field.
  • Must demonstrate a working understanding of the pertinent Quality Systems Regulations.
  • Proven ability to develop solutions to a variety of problems of moderate scope and complexity.
  • Capable of using Microsoft programs and ability to learn other systems.
  • Working knowledge of statistical methods and statistical application software.
  • Effective verbal and written communication skills.
  • Ability to work in teams and independently with minimal supervision.

Working Environment:


The ideal candidate will be able to work in a fast-paced environment with minimal supervision. They will be required to communicate effectively with cross-functional teams and maintain a positive work environment.


What We Offer:


MillenniumSoft offers a competitive salary and benefits package, as well as opportunities for professional growth and development.


How to Apply:


Interested candidates should submit their resume and cover letter to [insert contact information].

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