Quality Assurance Process Auditor

2 weeks ago


California, United States Medasource Full time

Position: Process Auditor - Med Device

Company: Medasource

Overview:

The role of a Process Auditor is essential in enhancing and refining manufacturing workflows for medical device production, particularly within the TMJ (temporomandibular joint) department.

Key Responsibilities:

  • Assess and enhance manufacturing workflows to boost efficiency, product yield, and overall quality.
  • Design, execute, and evaluate process validation studies to guarantee that processes are robust and well-regulated.
  • Offer technical guidance and assistance to production teams to address and resolve process-related challenges and deviations.
  • Maintain comprehensive process documentation, including standard operating procedures (SOPs) and production records.
  • Gather and scrutinize data, including operational metrics, to pinpoint trends, root causes, and opportunities for enhancement.
  • Ensure that manufacturing processes adhere to regulatory standards, industry guidelines, and internal policies.

Qualifications:

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


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