Senior Quality Engineer

2 days ago


Santa Clara, California, United States Cirtec Medical Full time
Job Summary

The Senior Quality Engineer will be responsible for developing and maintaining quality engineering methodologies, systems, and practices that meet customer and regulatory requirements. This role will provide quality engineering support to the new product development process, operations/production, and quality systems.

Key Responsibilities:
  • Provide quality engineering support for engineering product development and sustained manufacturing of catheters
  • Ensure quality requirements are communicated and met at suppliers
  • Review manufacturing records to perform lot release activity for catheters, including COC issuance
  • Provide quality project management support as needed for product transfers from development to validation to production
  • Verification/validation system owner responsible for the development and management of the verification/validation master plan along with the verification/validation determination
Requirements:
  • Bachelor of Science, preferably in biomedical, mechanical, or materials engineering discipline
  • 5 years minimum experience in medical device environment
  • Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office
  • Must possess excellent verbal communication, organizational, and management skills
  • Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement


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