Quality Engineer

  • location: Plainview, NY
  • type: Permanent
  • salary: $65,000 - $75,000 per year
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job description

Quality Engineer

Permanent position: Quality Engineer opportunity with a medical device company located near the Plainview, NY area. Reporting to the Quality Manager this position will be responsible for developing process and manufacturing procedures and controls, validation and verification of manufacturing processes, and implementing methodologies to reduce manufacturing variability. Local candidates or those willing to self relocate preferred. Client will consider entry level candidates.

Responsibilities for the Quality Engineer
  • Work with engineering and operations to ensure that the transfer of new products are in accordance with quality standards
  • Continual improvement activities to enhance the quality system
  • Create and maintain company quality documentation, such as quality manuals, quality procedures, etc.
  • Development of equipment and process validations (Installation Qualification, Operational Qualification and Performance Qualification) including gauge repeatability and reproducibility where required
  • Perform Design of Experiments and SPC for all production processes
  • Root cause analysis and implementation of corrective actions for process related concerns
  • Initiate and ensure timely resolution of supplier failure, corrective actions and preventive actions
Requirements for the Quality Engineer

  • Bachelor's Degree in Engineering or a Scientific field of study
  • Approximately 1 - 5 years Quality Engineering experience or a similar engineering role
  • Skilled in quality improvement techniques, including process validations and control
  • Understanding of data analysis tools including Excel, Word and Minitab
  • ISO systems (13485, 9001), CFR Part 820 and related FDA quality requirements experience preferred
  • Green or Black Belt in Six Sigma Quality is a plus
  • Excellent communication skills at all levels with internal and external clients

    Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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