Quality Engineer

* Create and review regulated documents associated with the design and manufacture of Cerus products such as SOPs, specifications, testing protocols and reports, quality control and reliability plans etc.
* Audit suppliers (testing and manufacturing) for compliance with quality requirements, regulations and international standards, observe processes and identify opportunities for improvement.
* Review in-process and final product specifications to evaluate and set quality requirements.
* Participate in devising and implementing methods and procedures for inspecting, testing and evaluating raw materials, components and finished products.
* Provide advanced techniques to ensure that quality is designed into products and processes, including Design/Process FMEA/HA, DOE, statistical process control, Six Sigma, etc.
* Perform analysis of production and process data to identify trends and recommend improvements to processes and procedures to reduce and control manufacturing process defects.
* Provide guidance on the development of verification and validation plans, test and sampling methods, sample size determination and acceptance criteria.
* Provide quality perspective in support of design control and change control activities.
* Leads or participates in cross-functional teams to support new product development, quality improvement, and cost savings projects.
* Provide support on the assessment and disposition of nonconforming material.
* Provide support on CAPA investigations and effectiveness assessments.
* Regularly interacts with other departments and suppliers regarding quality matters.
* Participate in Design Reviews and manufacturing process documentation for compliance.
* Provide staff training on regulatory requirements, specializing in GMP/QSR.
* Perform other related duties as required.

To find out more about Real Staffing please visit www.realstaffing.com