South San Francisco
California, United States of America
The Senior Device Quality Engineer works under limited supervision and provides support for quality engineering activities during product development. Job Responsibilities: - Accountable IMP device quality and technical-quality subject matter expert for product development device teams. May serve as IMP Device Quality lead for smaller scope product development device teams. - Provide quality engineering expertise on design controls, test method validation and equipment / process development for IMP device/combination product manufacturing. - Drive continuous improvement in combination product and device-related quality systems and business processes - Support root cause analysis and discrepancy investigations including the implementation of corrective actions - Provides technical device quality support for internal/external audits and vendor qualification. - Provide input on policies and procedures and act as a subject matter expert on applicable quality systems, standards or business processes (as required). - Establish work priorities to meet project targets and timelines. Maintain current status on all required job related training and strive to continuously improve knowledge and skills in quality, compliance, and technology. - Perform any other tasks as requested by Management to support quality oversight activities - Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
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Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.
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