Quality Assurance Engineer

Company Info
Radnor, PA, United States

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Company Profile


Quality Assurance Engineer


Sanborn, NY 

Job ID:


Job Description:

Under general supervision, develop, modify, apply, and maintain quality evaluation and control systems/protocols. 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.



Typical Daily Duties:

  • Use Quality Engineering principles, tools, and techniques to develop and optimize systems and processes so that they are aligned with company strategy and regulatory requirements.
  • Perform root cause analysis, identify and implement corrective actions for non-conformances and customer complaints
  • Review and approve quality assurance documents – risk assessments, validation protocols/reports, change managements records, CAPAs, Non-conforming material reports, trend reports.
  • Conduct audits (both internal and supplier) and monitor compliance with standards.
  • Collect, review, and interpret data for trend report, metrics, quality system review and complaints.
  • Responsible for Quality System maintenance.

Additional Duties:

  • Responsible for continual improvement activities to enhance the Quality System.
  • Develops and performs training to build quality awareness throughout the company.
  • Collaborate 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 multi-functional teams to resolve 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.
  • Demonstrates good communication and project management skills.
  • Collaborate with team members to support company goals.
  • Develop experiments by applying full and fractional factorial techniques (DOE).



  • Bachelor’s degree in a natural/life science field with proficiency in one of the following areas: Chemistry, Biology, Microbiology, or cell culture; or an equivalent combination of education, certification, and experience
  • Minimum 3 – 5 years’ experience in quality engineering role in a manufacturing facility.
  • Proven Understanding of ISO 9001:2015.
  • Can work independently and optimally in a team environment.
  • Can identify problems and communicate solutions in a constructive and positive manner.
  • Attention to detail; excellent organizational and record keeping skills. 
  • Excellent Technical Writing/ Report writing skills.

Nice to Have:

  • ASQ Certified Quality Engineer, or ASQ Certified Quality Auditor or currently pursuing certification
  • Process Validation or cleaning validation experience
  • Work experience in Chemical Industry
  • Working knowledge of problem-solving tools and Root Cause Analysis
  • Working knowledge and experience with LEAN, Six Sigma methodologies