Senior Quality Assurance Specialist

6 days ago


Gilbert, Arizona, United States Cooper Companies Full time
Job Title: Senior Quality Engineer

CooperVision, a division of CooperCompanies (NASDAQ: COO), is a leading manufacturer of soft contact lenses. The company produces a range of daily disposable, two-week, and monthly contact lenses featuring advanced materials and optics.

As a Senior Quality Engineer, you will play a key role in ensuring the seamless integration of quality assurance processes across the organization.

Key Responsibilities:
  • Collaborate with cross-functional teams to integrate quality assurance processes across various stages of the quality system.
  • Foster a culture of quality excellence by facilitating communication and coordination between quality assurance and other departments/sites.
  • Assess, define, and establish Key Performance Indicators (KPIs) to measure the efficiency and effectiveness of quality assurance processes.
  • Develop and implement strategies to enhance KPI performance and drive continuous improvement in quality outcomes.
  • Establish a robust system to monitor and analyze trends in quality data, including defect rates, customer complaints, and non-conformance incidents.
  • Utilize data analysis to identify patterns and potential areas for improvement, enabling proactive measures to address quality concerns.
  • Define and refine the validation process, ensuring alignment with regulatory requirements and industry best practices.
  • Develop comprehensive validation protocols, execute testing, and document results in accordance with established procedures.
  • Evaluate and refine the change control system, assessing potential impacts on product quality and regulatory compliance.
  • Implement necessary modifications to ensure a controlled change management process that minimizes risks and maintains quality standards.
  • Conduct a thorough evaluation of existing sampling regimes, ensuring their suitability and effectiveness in upholding product quality and regulatory compliance.
  • Recommend adjustments or enhancements to sampling plans based on meticulous data analysis and comprehensive risk assessment.
Requirements:
  • Five years or more of experience in Quality Engineering.
  • Strong applied knowledge of statistical tools, including DOE, Acceptance Sampling, and SPC.
  • Supervisory skills and good oral and written communication skills in both English and Spanish.
  • Highly motivated, self-starter, and responsible person with a strong work ethic.
  • Teamwork-oriented and able to work in a closed environment with normal noise levels and controllable temperature changes.
Work Environment:

Generally works in a closed environment, in office conditions, with normal level of noise and controllable changes of temperature.

Needs to stand, walk, and may be seated for a long period of time.

Uses hands to feel, finger, or handle and reach.

Works with a personal computer and programs to prepare documents or reports.

Applies communication skills (advanced reading, writing, and technical skills) and mathematical concepts knowledge to perform work and coordinate with others.



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