Senior Quality Assurance Engineer

4 weeks ago


Santa Clara, California, United States Cirtec Medical Full time

Job Summary:

The Principal Quality Engineer will lead the development and implementation of quality engineering methodologies, systems, and practices that meet customer and regulatory requirements. This role will focus on providing 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.
  • Develop and justify appropriate sampling plans with characterization of test/inspection methods.
  • Author, review, and/or approve documentation for Design Control activities for Design and Project Phase Reviews as well as Product Verification testing in cooperation with cross-functional engineering teams per project requirements.
  • Assist in qualification activities associated with supplier/vendor design characterization requirements for projects, to include audits and assessments.

Requirements:

  • Bachelor of Science, preferably in biomedical, mechanical, or materials engineering discipline.
  • 10 years minimum experience in medical device environment, or combination of education and relevant work experience.
  • 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.

About Us:

Cirtec Medical is a leading provider of manufacturing solutions for complex Class II and III medical devices. We specialize in providing comprehensive services from design and development to manufacturing and finished device assembly.



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