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Quality Engineer

Quality Engineer

Cynet SystemsEl Paso, TX
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Job Description :

  • Develop, change, and supervise Quality inspections to ensure the greatest value in quality control for the customer and the plant during the manufacturing process while meeting regulatory requirements.
  • Process monitoring and adjustment, process improvement, and product improvement, including corrective action plans to address process / product issues.
  • Documentation of activities, along with the review and maintenance of operating procedures as well as department-specific procedures.
  • Develop, implement, and improve Quality procedures applicable to the manufacturing process for assigned product lines.
  • Coordinate efforts with other Departments to establish controls and process capabilities for assigned product lines.
  • Actively support and provide input for process validation, process acceptance, internal and external audits, and resulting corrective actions.
  • Supervise the performance of assigned product lines regarding product quality, scrap, rejection rates, and other applicable metrics.
  • Review and develop changes in existing or proposed processes or requirements to achieve optimum performance and cost.
  • Assume a leadership role in analyzing and resolving process / product issues.
  • Develop or improve test methods for inspection, including Test Method Validation.
  • Monitor customer complaints and trends. Responding with specific corrective actions and customer interfacing as needed.
  • Ensure that all company safety rules and regulations are followed and promote general plant safety.
  • Develop / update and implement procedures to stay in sync with corporate and industry standards.
  • Day-to-day supervision and coordination of QA Technicians.
  • Other duties and projects, as assigned.

Education And / Or Experience :

  • Bachelor’s degree in engineering, and a minimum of four (4) years’ experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry Required,
  • Master’s degree in engineering, and a minimum of two (2) years' experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent regulated industry.
  • Preferred Qualifications :

  • Quality Engineering Certification (ASQ) or equivalent
  • Required Qualifications :

  • Ability to apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.).
  • Sophisticated statistical and risk assessment techniques.
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    Quality Engineer • El Paso, TX