Quality Engineer
in United States

Quality Engineer

$80,000 – $85,000


Location: Pennsylvania

Job Description

The Quality Engineer assures the quality of processes and products by performing audits, inspections, tests, defect analysis, trend analysis, programming & troubleshooting inspection equipment, calibration maintenance, and reporting on results of measurement standards. Assures consistent quality of suppliers and production by validating processes; providing documentation from measurement analysis, and helping departments understand the interpretation of collected data. Jobs that provide engineering technical support in this field should be assigned to this job family.


  • Identify and drive the resolution of internal quality issues.
  • Utilize Corrective Action/Preventive Action (CAPA) process to improve and sustain quality improvements to the QMS and/or product.
  • Utilize Supplier Corrective Action Request (SCAR) process to improve and sustain supplier quality.
  • Perform/participate in Supplier, Internal, and 3rd Party Audits.
  • Writing, execution, and review of Validation Protocols and Reports.
  • Routinely compile and report key quality metrics data to multiple organizational levels.
  • Lead routine Material Review Board (MRB) meetings to identify supplier quality issues and ensure timely disposition of nonconforming materials.
  • Participate in site daily management and provide support in resolving quality related issues
  • Ensure that the company’s products comply with the US Food and Drug Administration.
  • (FDA), local and state agencies and the International agencies regulations.
  • Performs other duties and task as assigned by supervisor/manager.

Job Requirements

  • Associates degree with 4 years of related experience in Quality OR
  • BS in Engineering or similar discipline
  • 3 to 5 years of Quality Assurance experience within an FDA regulated industry.


  • Working knowledge of Process Controls and Design Controls within a regulated Quality Management System (CFR 820).
  • Applicable knowledge of Risk Management and Supplier Quality management.
  • Experience in working within an ISO 13485 compliant Quality Management System.
  • Understanding of EU MDR desired.
  • Experience with root cause analysis, statistical technique, lean manufacturing, trending, Risk Management, and Six Sigma methodologies.
  • Prior experience in Operations highly desired.
  • Internal/Supplier auditing experience helpful.
  • Experience with SAP desired.
  • Excellent problem solving and presentation skills, as well as the ability to quickly learn a new environment.
  • Cross functional experience with products, engineering processes and manufacturing processes to maintain credibility to communicate and influence change at all levels within the organization.


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