Quality Engineer II (No C2C / No Sponsorship)

Job Title : Quality Engineer II

• No C2C / No Sponsorship

Location : San Diego, CA - 100% onsite

Duration : 6+ months (Potential to extend and / or convert to permanent)

Pay : $45 / hr W2 Only

Position Details : Quality Reviews and assessment of Non conformances, Change orders. Review and approve development studies. Attend project meetings and draft Validation protocols & reports, assist in execution.

Work experience desired : Validation experience in custom equipment. Design validation protocols and statistical sampling. Risk assessment in FMEA format. Good at problem solving. Working cross functionally with other departments.

Job Summary

The Quality Engineer II is responsible for validation of analytical methods, cleaning, production process, equipment qualification, facilities / utilities qualification, and raw materials qualification. Additionally, generate and maintain process FMEA for production processes, perform risk assessments for process related non-conformances and planned deviations, provide support and content for regulatory submissions, write master validation plans, protocols and reports, support equipment and facilities change controls, and perform validation impact assessment for change orders.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

transfer, risk management and specification development.

change controls (Equipment or Facilities).

Qualifications

Education

Experience