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.
Provide Design Control guidance to product development under direction from Life Cycle Teams (LCT). Act as the single point representative for all Quality Management System activities for Project Teams.
Review and approve documentation consistent with design control regulations/guidance, Roche Diagnostic Divisional Standards and business area/unit specific processes and procedures. Documentation includes, but is not limited to, design control-related documents such as design development plans, risk management plans/reports, customer requirements, product requirements, technical performance verification protocols/reports, clinical study plans/reports, design transfer documents, labeling, and milestone documentation.
Communicate critical product quality or compliance-related issues to Quality Management to ensure alignment with Quality policy and objectives. Participate in difficult discussions, challenge the status quo, and identify mutually beneficial compliant solutions with cross-functional colleagues at the Project Team level. Work closely and partner with DQA colleagues within and across sites to ensure consistent application of design control-related processes.
Author Quality Reports. Advise and support Project Teams during the planning of milestones to complete required deliverables. Assist management in assessment of whether the project has met requirements to pass milestone.
Provide feedback on new or revised SOP’s associated with design control activities/compliance. May be the key contributor/coordinator for Quality feedback on SOP revisions working closely with the respective SOP owner and DQA leadership.
Supports internal and external audits/inspections. May Proxy for QFL as requested for LCT. Activities may include nonconformance review and approval, and document change review and approval within Trackwise. Activities may include equipment installation qualification review and approval.
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.
Internal Number: 201901-100867
About Roche Molecular Solutions
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