Manufacturing Quality Lead

3 days ago


Irvine, California, United States Cordis Full time
Company Overview">

Cordis, a leading medical device company, is dedicated to revolutionizing healthcare through innovative technology and commercialization of advanced drug-device combination products. Our mission is to address unmet medical needs by creating next-generation solutions. With headquarters in Switzerland and offices in Germany, Singapore, the UK, and the United States, Cordis fosters a culture of quality excellence.

About the Role

This Principal Quality Assurance Engineer position plays a critical role in ensuring that our medical devices meet the highest quality standards throughout the manufacturing process. The successful candidate will oversee and manage operations quality programs, initiatives, and guide the operations team through production scale-up, end-to-end product realization, and associated quality deliverables.

Key Responsibilities
  • Ensure compliance with regulatory standards and internal quality requirements
  • Lead the engineers through continuously identifying and implementing process improvements to enhance product quality, reduce waste, and optimize manufacturing efficiency
  • Conduct risk assessments related to manufacturing processes and identify potential areas for risk mitigation to ensure the safety and efficacy of medical devices
Requirements
  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field
  • At least 8 years in medical device production development
  • Previous experience with product lifecycle (post-market) commercial support
  • Previous experience leading programs supporting business and regulatory strategy
Compensation

The estimated salary for this position is $93,816 - $160,000 per year, depending on skills, education, experience, job-related knowledge, and location. This is a full-time position, and US work authorization is required.



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