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Process Engineering Auditor

3 months ago

Ventura, United States Medasource Full time

Position: Process Engineering Auditor - Med Device

Location: Ventura, CA

Start Date: ASAP

Duration: 12+ month contract


Summary

As a Process Engineering Auditor, you will play a critical role in optimizing, scaling up & troubleshooting manufacturing processes for the production of medical device products.


Qualifications:

  • B.S. in mechanical engineering, or a related field
  • At least 1 years’ experience in med device process development and manufacturing
  • Knowledge of regulatory requirements for med device manufacturing
  • Experience in process trouble shooting
  • Hands on experience in validation within med device
  • Solid project management experience with a demonstrated ability to plan, execute and oversee cross-functional projects

Responsibilities:

  • Continuously evaluate and improve medical device manufacturing processes to enhance efficiency, yield, and product quality.
  • Develop, implement, and analyze process validation studies to ensure robust, well-controlled processes.
  • Provide technical expertise and support to manufacturing teams for the resolution of process-related issues & deviations.
  • Maintain detailed process documentation, standard operating procedures (SOPs) and batch records.
  • Collect and analyze data, including process data, to identify trends, root causes, and areas for improvement.
  • Ensure manufacturing processes comply with regulatory requirements, industry standards and company policies.