The Design Quality Assurance (DQA) Principle Scientist I, provides Quality functional support for design/development projects following Roche Diagnostics established Life Cycle Management processes. This position will provide DQA support for approved projects entire product life cycle, including design/development, manufacturing, and post-market phases. This position will also be involved in continuous improvements for design-control related process and ensuring QMS compliance at designated sites. This position will support our Pleasanton, CA and Los Gatos, CA offices.
Bachelor’s degree in Chemistry, Biochemistry, Molecular Biology or related scientific discipline or equivalent combination of education and work-related experience.
Preferred: Master’s degree in Chemistry, Biochemistry, Molecular Biology or related scientific discipline or equivalent combination of education and work-related experience.
Job Related Experience:
5 Years experience under established quality regulations, including intermediate knowledge of medical device or pharma processes. Strong track record of successful participation on cross-functional teams.
Preferred: 8 Years Development, Manufacturing and/or Quality Assurance experience under established quality regulations, intermediate level knowledge of in-vitro diagnostic products including nucleic acid based products related to RMS products and processes. Proven interactions with all Quality Management and other departments (Development, Regulatory Affairs, Operations). Strong track record of successful participation on cross-functional technical/project teams.
Other Qualifications: Working knowledge of QSR/cGMP, ISO and Design Controls. Excellent oral, written and interpersonal communication skills are required.