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 .