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Quality Systems Engineer I/II

1 month ago

Rancho Santa Margarita, California, United States Applied Medical Full time
Job Description

Applied Medical is a leading medical device company that is committed to innovation and excellence. We are seeking a highly skilled Quality Systems Engineer I/II to join our team and contribute to the development and validation of our medical devices.

Key Responsibilities:
  • Develop and implement test methods to ensure product performance and effectiveness.
  • Design and create test equipment to meet the specific requirements of internal and external stakeholders.
  • Validate test methods through statistical analysis and documentation of findings.
  • Investigate and document anomalies discovered during testing.
  • Provide technical leadership and mentoring to team members.
  • Ensure compliance with quality systems, safety regulations, and company policies.
Requirements:
  • Bachelor's Degree or higher in Engineering or a scientific field.
  • Experience in test method development and validation.
  • Basic understanding of statistical techniques.
  • Experience in performing Gage R&R, ANOVA, and measurement system analysis using MINITAB or equivalent software.
Preferred Qualifications:
  • Minimum of one year's experience in medical device, healthcare, or other regulated industries.
  • Experience in Medical Device Quality Systems standards and regulations.
  • Experience in using Minitab, SolidWorks, or similar software.
  • Experience in using SAP Product Lifecycle Management or a similar Enterprise Resource Planning system.

We offer a competitive compensation range, comprehensive benefits package, training and mentorship opportunities, and a range of benefits designed to enhance your career and life.