Quality Assurance Engineering Manager

1 month ago


San Jose, California, United States CathX Full time
Job Description:

CathX Medical is seeking an experienced Quality Assurance Engineer to lead the design assurance team in ensuring high-quality medical products. This role involves designing and implementing quality control processes, collaborating with cross-functional teams, and maintaining compliance with regulatory standards.

About CathX Medical:

CathX Medical is a leading developer of innovative medical devices. Our team is committed to delivering exceptional products that meet the highest standards of quality and safety.

Key Responsibilities:
  • Lead the design assurance team in developing and implementing quality control processes
  • Collaborate with cross-functional teams to ensure product quality and compliance with regulatory standards
  • Analyze data to identify trends and areas for improvement
  • Develop and implement corrective actions to address quality issues
  • Maintain documentation and records related to quality control processes
Requirements:
  • Bachelor's degree in Science, Engineering, or Manufacturing
  • At least 5 years of experience in quality engineering or a related field
  • Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971
  • Excellent communication and interpersonal skills
  • Ability to travel as necessary
Estimated Salary:

$120,000 - $150,000 per year



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