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Senior Quality Engineer- Onsite-Irvine, CA- CONTRACT-ASAP

  • Location: Irvine
  • Salary: Negotiable per hour
  • Job Type:Contract

Posted 20 days ago

  • Sector: Engineering & Quality, Medical
  • Contact: Ben Upton
  • Duration: 6 months
  • Start Date: ASAP
  • Expiry Date: 18 February 2023
  • Job Ref: JN -012023-476579

We are looking for a talented Senior Quality Engineer to join an amazing medical technology company based onsite in Irvine, CA! This will be an onsite role for an initial 6 month contract with the opportunity for extension. The client is offering a highly competitive contract rate for the right candidate.

Key skills and requirements:

  • Investigate manufacturing product quality and compliance issues reported internally and/or from the field, analyze results, determine root causes, and initiate and review reports (e.g., Non-Conformances, CAPA, Audit resolutions)
  • Assess reported events against established procedures and risk control documentation for clinical and compliance risks and escalate to Quality Management as needed.
  • Initiate and manage Enterprise Change Request (ECR) to implement procedure changes.
  • GDP and GMP proficiency and experience working in medical device, pharma, or biotech industry
  • Understanding of manufacturing, quality, and risk management standards.
  • Experience working with inspection and measurement tools & equipment (e.g. microscope, TAPPI, burst tester, tensile tester)
  • Bachelor's degree in Engineering or Scientific field with a minimum of 4 years relevant experience in Quality Engineering, Quality Operations, Quality Systems or Manufacturing; OR Master's degree in Engineering or Scientific field with 3 years of experience.

If you are available and meet the above requirements please apply ASAP with your latest resume to be considered .

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