South San Francisco
California, United States of America
Location: South San Francisco, CA The Principal Device Quality Engineer works independently and provides oversight of quality engineering activities during product development and/or commercial product care. Job Responsibilities: Accountable IMP device quality lead and technical-quality subject matter expert for product development device teams and/or commercial product care. Provide quality engineering expertise on design controls, method validation and equipment / process development for IMP combination product manufacturing. Drive continuous improvement in combination product and device-related quality systems and business processes Help maintain current knowledge by interfacing with industry peers, partners and regulators. Supports root cause analysis in the implementation of corrective actions Provides technical device quality support for internal/external audits and vendor qualification. Collaborate on and /or author policies and procedures and act as a trainer / subject matter expert on applicable quality systems, standards or business processes (as required). Set personal performance goals and provide input to departmental objectives and establish work priorities to meet 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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