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Quality Assurance Engineer

  • Job type: Permanent
  • Location: Rochester, New York
  • Salary: Competitive
  • Job reference: 221771/001_1538485949
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 02/10/2018

Role: Quality Assurance Engineer

Location: Rochester, New York

The Quality Assurance Engineer with provide assure regulatory compliance and best industry practices through providing quality engineering support and development assistance. The Quality Assurance Engineer is also responsible for both leading and supporting Continuous Improvement Initiative of the Quality System.

Essential functions of the Quality Assurance Engineer:

  • Assure that all manufacturing components and processes are compliant with FDA regulations

  • Develop dFMEAs, pFMEAs and risk reports to support new product development

  • Lead and provide support to the Quality System Continuous Improvement Initiatives

  • Identify the statistical methods relevant to manufacturing processes in order to determine the quality improvement parameters

  • Develop and consistently update work instructions, procedures, quality plans, inspections plans and risk analyses

  • Develop systems that support and monitor both KPIs (such as yield, cycle time) and good manufacturing processes (GMP)

  • Perform and facilitate root-cause investigations of CAPA activity, internal non-conforming material and customer complaints

Additional Responsibilities of the Quality Assurance Engineer:

  • Making recommendations through prepared reports that summarize data

  • Support the validation of processes and equipment by participating in the manufacturing capability/reliability development process

  • Development and analysis of verification and validation studies

  • As required, membership to the internal audit team

Education and Experience:

  • 3-5 years of experience in Quality Engineering (medical device, automotive, aerospace preferred)

  • Bachelor's degree in a technical discipline

  • Excellent verbal and written communication skills

  • Excellent computer skills including skilled understanding of Quality Engineering applications such as SPC, CpK, DOEs, FMA, dFMEA, pFMEA

  • Familiarity with basic LEAN concepts, and advance knowledge

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