Quality Engineer/QA Manager Lab Support, A Division Of On Assignment -
Fremont, CA
Coordinate the reporting, analysis, and resolution of material non-conformance incidences. Participate in Material Review Board meetings, as needed.
Develop quality assurance specifications, test methods, sampling plans and related written procedures.
Facilitate the launching of new or improved products/processes, and the transfer of technology from development to commercialization from a Quality and manufacturing perspective.
Write and coordinate efforts for the development and implementation of new and updated Quality System procedures such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs, development and task force projects.
Coordinate the identification, assignment, monitoring, and completion of product improvement projects in cross-functional teams.
Conduct statistical analysis (F-test, t-test, ANOVA, normality tests, etc) and generate trend reports for projects on an as-needed basis.
Utilize Quality Engineering tools and techniques to establish sampling plans, develop quality plans, conduct and participate in FMEA activities, conduct process and systems audits and to assist in specification development.
Conduct quality audits and develop subsequent preventive action programs.
Maintain QSR systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production QSR compliance in coordination with the Document Control, Clinical, Regulatory, and Research and Development functions.
Conduct returned product analysis investigations and DHR review. Perform trending on complaint rates and provide feedback to management team.
