Quality Assurance Engineer

Company Info
Avantor
Radnor, PA, United States

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Title:

Quality Assurance Engineer

Location:

Paris, KY 

Job ID:

71807
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Job Description:

The Quality Assurance Engineer will develop, modify, apply, and maintain quality evaluation and control systems/protocols. They will also devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment; Design and analyze inspection and testing processes, mechanisms, and equipment; Conduct quality assurance tests and performing statistical analysis to assess the level of control and manage product quality risks.

Work Schedule: 2nd Shift (Monday-Friday, 2:30pm-11:00pm/some flexibility)

MAJOR JOB DUTIES AND RESPONSIBILITIES:

  • Responsible for Quality System maintenance.
  • Performs root cause analysis and implementation of corrective action for process related issues.
  • Identifies statistical methods relevant to the manufacturing process.
  • Responsible for continual improvement activities to enhance the Quality System.
  • Develops and performs training to build quality awareness throughout the company.
  • Interfaces with Manufacturing, Research and Development and Engineering to ensure transfer of newly developed products that are in accordance with approved data and analysis.
  • Conducts audits, including closing out audit findings, creating audits finding reports and works with cross functional teams to determine proper corrective and preventive actions.
  • Assists in creation and maintaining quality documentation.
  • Implements and maintains Statistical Process Control (SPC) for products and identifies potential process improvements.
  • Conduct Active Pharmaceutical Ingredient product review.
  • Evaluate impact of process improvement effort and manufacturing deviation on process validation and product design.
  • Develop experiments by applying full and fractional factorial techniques (DOE).

QUALIFICATIONS:

  • Bachelor of Science degree in Chemistry, Chemical Engineering, Material Science or related discipline.
  • 3 – 5 years’ experience in quality engineering role in chemical, rubber, or plastic industries.
  • ASQ Certified Quality Engineer, or are currently pursuing certification is preferred.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Knowledge of ISO 9000/ AS9100.
  • Working knowledge and experience with LEAN, Six Sigma methodologies.
  • Working knowledge in Design of Experiments (DOE), and ability to manage implementation of improvements.
  • Proficiency working with Microsoft Excel, Word.
  • Experience with Minitab or other statistical software strongly desirable.
  • Understanding of statistical process and quality control principle.
  • Skilled in metrology tools.

ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT:
Typically works in a lab environment with adequate lighting and ventilation and a normal range of temperature and noise level. At times, may be exposed to a variety of different chemicals including flammables, corrosives, oxidizers and others.