Quality Engineer

Job Requisition: 6916

Quality Engineer (Direct Hire)


Job Requisition: 6916

Description for Quality Engineer:

The Quality Engineer will work closely with operations and engineering to reduce scrap and drive continuous improvement activities to reduce customer complaints and lower the response time. This position will investigate internal and external quality issues and identify root cause, using data analysis, data trending and periodic reporting 

Responsibilities for Quality Engineer:

  • Participate and perform equipment process optimization and validations.
  • Participate in optimization of CFM’s.
  • Participate and perform discrepant material disposition.
  • Recommend and update existing inspection plans, control plans, test methods, and standard operating procedures.
  • Participate in sample size determination, statistical analysis, training, and root cause analysis.
  • Participate in process failure modes and effects analysis (FMEA).
  • Participate in various manufacturing projects such as process development, cost reduction and quality improvement initiatives.
  • Collect, review, analyze, and trend quality indicators for monthly and quarterly reviews.
  • Participate in problem solving teams using standardized investigation processes/tools.
  • Performs routine engineering assignments of related tasks which are typically a focused portion of larger projects. These tasks provide experience and familiarization with the engineering staff, methods, techniques, theories, Corporate and division SOP's, policies and projects.
  • Support documentation development work including writing specifications for manufacturing or scientific test results.
  • Ability to solve routine design and engineering tasks with some assistance.
  • Assists in the preparation and participation in technical reviews of products.
  • Support in management, implementation, and documentation of IQ, OP, PQ.
  • Participate/Lead cross-functional teams in continuous quality improvement projects.
  • Conducts Internal Audits and addresses observations.
  • Other tasks and duties as assigned.
  • Ensure product and process validations are completed.

Requirements for Quality Engineer:

  • Experience in Medical Devices or Pharmaceutical Industry (preferred)
  • Bachelor’s degree in an Engineering field required
  • Ability to independently complete problem-solving tasks
  • Demonstrated knowledge and understanding of Statistical Process Controls
  • Basic understanding of engineering and mathematics principles
  • Understand interpretation of drawings, specifications, blueprints, and etc.
  • Able to use inspection and measuring instruments such as calipers, micrometers, tensile strength tester (e.g. Instron or Chatillion)
  • Highly motivated, detail-oriented, eager to learn
  • Ability to use MS Office Tools such as Word, Excel, Project, and MiniTab®
  • Strong analytical, problem solving and teamwork skills are required
  • Able to follow instructions in all formats: written, verbal, and electronic
  • Excellent written and oral communication skills
  • Excellent interpersonal and presentation skills
  • Ability to develop and implement strategies
  • Excellent time management, prioritization abilities, and strong project management skills
  • Demonstrated ability to initiate and drive continuous improvement



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