Quality Management Specialist

5 days ago


Irvine, California, United States Cordis Full time

Cordis is committed to fostering an inclusive work environment where all teammates feel seen, heard, and appreciated. As a Quality Management Specialist, you will be part of a dynamic team driving innovation and excellence in medical device production. Your primary focus will be on developing, implementing, and continuously improving quality management systems to ensure compliance with regulations, standards, and customer requirements.

Responsibilities:

  1. Oversight of operations quality programs and initiatives
  2. Guiding the operations team through production scale-up and end-to-end product realization
  3. Ensuring compliance with regulatory standards and internal quality requirements
  4. Leading process improvements to enhance product quality and manufacturing efficiency
  5. Conducting risk assessments and mitigating risks to ensure device safety and efficacy

Requirements:

  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field
  • At least 8 years in medical device production development
  • Experience with product lifecycle (post-market) commercial support and leading programs supporting business and regulatory strategy
  • Strong engineering and quality background, with excellent communication and leadership skills

Salary: $93,816 - $160,000 per year, depending on qualifications and experience.



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