Sr Quality Engineer I

Gilead Sciences • Foster City, CA

30d

About The Position

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description This opportunity is an exciting and challenging role that will be key to Gilead's success as we work towards bringing new combination products, such as pre-filled syringes and autoinjectors, to market. As the Sr Quality Engineer I, you will be a key Quality person supporting these new product lines in the commercial stage, starting with collaborating with the design and development team on Design Transfer. We are looking for a Quality professional to ensure that we have end-to-end Quality support of our combination products.

Requirements

• Must have 6+ years of experience in the medical device industry and a Bachelor’s degree in science or engineering related field OR 4+ years of relevant experience with a Master’s degree.
• Demonstrates in-depth knowledge of Quality principles, concepts, industry practices, and standards.
• Previous experience in Design Transfer to contract manufacturers.
• Quality experience in both clinical and commercial products.
• Well-versed in risk management methodologies and their application.
• Able to work independently and in a global team environment, and with all levels of personnel within the organization.
• Possess excellent interpersonal relationship skills.
• Demonstrates understanding of U.S. and international quality systems regulations/standards to adopt best in class systems/processes and drive continuous improvement initiatives.

Nice To Haves

• Previous experience with combination devices is preferred (i.e., Autoinjectors, pre-filled syringes).
• Knowledge of ISO 14971 Risk Management tools (e.g., Hazard Analysis / or Failure Mode Effects Analysis (FMEA)) is preferred.
• Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry- recognized professional organizations is preferred.

Responsibilities

• Develop key relationships and interface extensively with internal stakeholders and contract manufacturers to address and resolve technical issues related drug-device combination product, process and quality issues.
• Identify gaps in existing processes as well as the need for new processes.
• Lead cross-functional teams for solution development and implementation
• Writes and or implement changes to controlled documents (e.g., SOPs, Specifications, WIs, etc.) as needed.
• Create, revise, execute SOPs to support combination product quality governance during the Design Transfer or in the commercial stage.
• Work with management and department personnel to achieve goals and strategic initiatives.
• Executes changes to quality processes to ensure conformance and continuous improvement.
• Ensure that changes to commercial products are conducted in accordance with FDA QSR/QMSR, ISO 13485, and other applicable standards.
• Maintain compliance with global Risk Management processes in accordance with ISO 14791 and other applicable standards.
• Work cross-functionally with Subject Matter Experts from R&D, Clinical, and Operations to ensure the risk process is applied comprehensively.
• Participate in annual product reviews and perform periodic review and update of DHF and RMF.
• Review design inputs, outputs, and verification/validation results.
• Analyze process data and ensure processes are capable and in control.
• Maintains expertise in both current and emerging requirements and quality trends as they relate to Pharmaceuticals, Medical Devices, and Combination Products worldwide.
• Supports due diligence and internal or external audits/inspections as needed.
• Create and provide Quality training as needed for cross functional stake holders and CMOs.
• Support complaints investigations and filter information back to the design and development team and CMOs.
• Stay abreast of evolving regulatory requirements and ensure commercial products comply with applicable standards.

Benefits

• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.
• For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees