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Principal Quality Engineer

1 month ago

Santa Clara, California, United States Cirtec Medical Full time
Job Title: Principal Quality Engineer

Cirtec Medical is seeking a highly skilled Principal Quality Engineer to join our team. As a key member of our quality engineering team, you will be responsible for developing and implementing quality engineering methodologies, systems, and practices that meet customer and regulatory requirements.

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

What We Offer:

  • Competitive salary range: $125,000-187,000
  • Opportunity to work with a leading provider of manufacturing solutions for complex Class II and III medical devices
  • Collaborative and innovative work environment
  • Professional development opportunities

Cirtec Medical Corporation is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating a culture that values innovation, respect, transparency, and communication.