Quality Assurance Process Auditor

2 weeks ago


California, United States Medasource Full time

Position: Process Auditor - Med Device

Company: Medasource

Role Overview:

As a Process Auditor, you will be instrumental in enhancing, scaling, and troubleshooting production methodologies for medical device manufacturing, specifically within the TMJ sector (jaw devices).

Key Qualifications:

  • Bachelor's degree in mechanical engineering or a related discipline.
  • A minimum of one year of experience in medical device process development and production.
  • Familiarity with regulatory standards governing medical device manufacturing.
  • Proven experience in process troubleshooting.
  • Hands-on experience in validation processes within the medical device sector.
  • Strong project management skills with a track record of planning, executing, and overseeing cross-functional initiatives.

Core Responsibilities:

  • Regularly assess and enhance manufacturing processes for medical devices to improve efficiency, yield, and product quality.
  • Design, implement, and evaluate process validation studies to ensure robust and well-controlled operations.
  • Offer technical guidance and support to production teams for resolving process-related challenges and deviations.
  • Maintain comprehensive process documentation, including standard operating procedures (SOPs) and batch records.
  • Gather and analyze data, including process metrics, to identify trends, root causes, and opportunities for improvement.
  • Ensure that manufacturing processes adhere to regulatory standards, industry benchmarks, and company policies.


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